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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA225792-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study is a randomized controlled trial (RCT) to test the efficacy of a Behavioral Activation and Problem Solving (BA/PS) approach to improving activity participation over time as compared to an attention control condition within a sample of 300 breast cancer survivors reporting reduced activity participation after completing cancer treatment.
Assessments will be administered via telephone by a research assistant blind to group assignment. Participants will complete outcome assessments upon enrollment (T1) and at 8 weeks (T2), 20 weeks (T3) and 44 weeks (T4) later. The T2 assessment captures the short-term outcomes of the most intensive part of the intervention (i.e., after six weekly sessions). The T3 assessment will capture the short-term outcomes at the end of the full intervention. The T4 assessment explores the sustained effect of BA/PS (six months after BA/PS ends). The study aim is to test whether the BA/PS intervention affects the "slope" of functional recovery over time. With the longitudinal data, the investigators will also be able to explore the pace of improvement and whether the two groups differ at these clinically relevant time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Behavioral Activation/ Problem Solving Intervention | Experimental | BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model. |
|
| Attention Control Condition | Active Comparator | Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Behavioral Activation/ Problem Solving Intervention | Behavioral | The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week. |
| Measure | Description | Time Frame |
|---|---|---|
| Participation Satisfaction in Social Roles and Activities: PROMIS | The Patient Reported Outcomes Measurement Information System (PROMIS): Satisfaction with Social Roles and Activities measures satisfaction with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater satisfaction with daily routines and activities). | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast. |
| Participation Ability in Social Roles and Activities | The Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form 8a measures participation with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater ability to participate in daily routines and activities). | The overall treatment effect will be computed as between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. |
| Productivity | Instrument name: Disability Days section of the Medical Expenditure Panel Survey (MEPS). Range: 0- 30 days. Subscales: N/A. Interpretation: Higher values indicate lower productivity. | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast. |
| Work Productivity | The Work Limitations Questionnaire-Short Form (WLQ-SF) assesses productivity with an overall score indicating the percentage decrement in productivity in the previous two weeks. Scores range 0-100% with higher scores indicating greater decrement in productivity. | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | The Functional Assessment of Cancer Treatment (FACT) - General measures quality of life. The physical, social, and functional subscale scores can range 0-28 and the emotional subscale score can range 0-24; higher scores indicate better well-being. Overall score was calculated by summing the four subscales; overall scores can range from 0-108 with higher scores indicating better quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Coping | The Brief COPE measures adaptive coping. Range for each subscale (positive reframing, active coping, planning): 2-8; higher values indicate more adaptive coping. Subscales items are summed; no total score. | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Lyons, ScD | MGH Institute of Health Professionals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-1210 | United States | ||
| Dartmouth Hitchcock Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38517442 | Derived | Lyons KD, Wechsler SB, Ejem DB, Stevens CJ, Azuero A, Khalidi S, Hegel MT, Dos Anjos SM, Codini ME, Chamberlin MD, Morency JL, Coffee-Dunning J, Thorp KE, Cloyd DZ, Goedeken S, Newman R, Muse C, Rocque G, Keene K, Pisu M, Echols J, Bakitas MA. Telephone-Based Rehabilitation Intervention to Optimize Activity Participation After Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e242478. doi: 10.1001/jamanetworkopen.2024.2478. | |
| 32060166 |
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19 participants were enrolled and then excluded from the study before assignment to groups. 2 were excluded due to screen failure and 17 were excluded because they did not complete the baseline assessment.
Recruitment occurred between August 2019 and April 2022. Participants were recruited via Dartmouth College, the University of Alabama at Birmingham (UAB), and via Facebook.
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| ID | Title | Description |
|---|---|---|
| FG000 | The Behavioral Activation/ Problem Solving Intervention | BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model. The Behavioral Activation/ Problem Solving Intervention: The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week. |
| FG001 | Attention Control Condition | Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition). Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | The Behavioral Activation/ Problem Solving Intervention | BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model. The Behavioral Activation/ Problem Solving Intervention: The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participation Satisfaction in Social Roles and Activities: PROMIS | The Patient Reported Outcomes Measurement Information System (PROMIS): Satisfaction with Social Roles and Activities measures satisfaction with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater satisfaction with daily routines and activities). | All available data were used for the linear contrasts. See Participant Flow for reasons for missing data. | Posted | Mean | Standard Error | T-score | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast. |
|
44 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The Behavioral Activation/ Problem Solving Intervention | BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model. The Behavioral Activation/ Problem Solving Intervention: The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathleen Lyons | MGH Institute of Health Professions | 617-643-5372 | klyons2@mghihp.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2023 | Feb 12, 2024 | Prot_SAP_000.pdf |
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The investigators will recruit 300 women over the age of 18 reporting participation restrictions after completing curative treatment for Stage 1-3 breast cancer within the past year. Half of the participants will be randomized to the 4-month BA/PS intervention which consists of 6 weekly telephone calls followed by 3 monthly telephone calls. BA/PS is designed to teach problem-solving and action planning to promote functional recovery. The other half of participants will be assigned to an attention control condition providing education about survivorship topics. This control condition will allow us to account for the effect of time and history, and the non-specific effects of attention
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Assessments will be administered via telephone by a research assistant blind to group assignment.
|
| Attention Control Condition | Behavioral | The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. |
|
| The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. |
| Goal Adjustment | Instrument name: Goal Disengagement and Goal Reengagement Scale (GDGRS). Range: 4 to 20 for goal disengagement and 6 to 30 for goal reengagement. Subscales: goal disengagement and goal reengagement (subscale items are averaged, no total score). Higher values indicate greater tendency to disengage or re-engage with goals. | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. |
| Distress | Instrument name: Hospital Anxiety and Depression Scale (HADS). Range for each subscale (no total score): 0-21. Subscales: anxiety and depression. Higher values indicate greater anxiety and depression. | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. |
| Occupational Performance | Instrument name: Canadian Occupational Performance Scale. The participant rates each activity with Likert scales for three characteristics: satisfaction (1- 10), performance (1-10), and importance (1 - 10). Interpretation: Higher values indicate higher occupational performance. | The overall treatment effect will be computed as the between-group difference from Session 1 (baseline) and Session 9 (approximately week 20), estimated with a linear contrast. |
| Lebanon |
| New Hampshire |
| 03756 |
| United States |
| Stevens CJ, Hegel MT, Bakitas MA, Bruce M, Azuero A, Pisu M, Chamberlin M, Keene K, Rocque G, Ellis D, Gilbert T, Morency JL, Newman RM, Codini ME, Thorp KE, Dos Anjos SM, Cloyd DZ, Echols J, Milford AN, Ingram SA, Davis J, Lyons KD. Study protocol for a multisite randomised controlled trial of a rehabilitation intervention to reduce participation restrictions among female breast cancer survivors. BMJ Open. 2020 Feb 13;10(2):e036864. doi: 10.1136/bmjopen-2020-036864. |
| BG001 | Attention Control Condition | Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition). Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Employment Status | Count of Participants | Participants |
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| Education Level | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Number of Dependent Children Living at Home | Count of Participants | Participants |
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| Insurance Status | Count of Participants | Participants |
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| Household Income | Count of Participants | Participants |
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| Rurality | Count of Participants | Participants |
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| Cancer Stage | Cancer stage was self-reported by participants who were recruited via Facebook, and for all other participants, it was collected via electronic medical record review. Higher stage indicates more advanced disease state. | Count of Participants | Participants |
|
| Cancer Treatment | Count of Participants | Participants |
|
| Time Since End of Primary Cancer Treatment | Count of Participants | Participants |
|
| Disability Days | Mean | Standard Deviation | Days |
|
| PROMIS: Satisfaction with Social Roles & Activities | The Patient Reported Outcomes Measurement Information System (PROMIS): Satisfaction with Social Roles and Activities measures satisfaction with daily routines and activities. Raw scores were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater satisfaction with daily routines and activities). | Mean | Standard Deviation | T-score |
|
| PROMIS: Ability to Participate in Social Roles & Activities | The Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities measures self-reported ability to participate in daily routines and activities. Raw scores were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater ability to participate in daily routines and activities). | Mean | Standard Deviation | T-score |
|
| Work Limitations Questionnaire scale score | Mean | Standard Deviation | units on a scale |
|
| Quality of Life, FACT-G | The Functional Assessment of Cancer Treatment (FACT) - General measures quality of life. The physical, social, and functional subscale scores can range 0-28 and the emotional subscale score can range 0-24; higher scores indicate better well-being. Overall score was calculated by summing the four subscales; overall scores can range from 0-108 with higher scores indicating better quality of life. | Mean | Standard Deviation | units on a scale |
|
| Brief COPE | Range for each subscale (positive reframing, active coping, planning): 2-8; higher values indicate more adaptive coping. Subscales items are summed; no total score. | Mean | Standard Deviation | units on a scale |
|
| Goal Adjustment Scale | Scores range from 4-20 for the goal disengagement subscale and 6-30 for goal reengagement subscale; higher scores indicate greater tendency to disengage or re-engage with goals. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety Depression Scale (HADS) | Mean | Standard Deviation | units on a scale |
|
| Work and Social Adjustment Scale (WASA) score | The Work and Social Adjustment Scale (WASA) measures self-reported disability; higher score indicating greater disability. Scores range 0-40. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Attention Control Condition | Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition). Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. |
|
|
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| Primary | Participation Ability in Social Roles and Activities | The Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form 8a measures participation with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater ability to participate in daily routines and activities). | All available data were used for the linear contrasts. See Participant Flow for reasons for missing data. | Posted | Mean | Standard Error | T-scores | The overall treatment effect will be computed as between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. |
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| Primary | Productivity | Instrument name: Disability Days section of the Medical Expenditure Panel Survey (MEPS). Range: 0- 30 days. Subscales: N/A. Interpretation: Higher values indicate lower productivity. | All available data were used for the linear contrasts. See Participant Flow for reasons for missing data. | Posted | Mean | Standard Error | days | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast. |
|
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| Primary | Work Productivity | The Work Limitations Questionnaire-Short Form (WLQ-SF) assesses productivity with an overall score indicating the percentage decrement in productivity in the previous two weeks. Scores range 0-100% with higher scores indicating greater decrement in productivity. | All available data were used for the linear contrasts. See Participant Flow for reasons for missing data. | Posted | Mean | Standard Error | score on a scale | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. |
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| Secondary | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | The Functional Assessment of Cancer Treatment (FACT) - General measures quality of life. The physical, social, and functional subscale scores can range 0-28 and the emotional subscale score can range 0-24; higher scores indicate better well-being. Overall score was calculated by summing the four subscales; overall scores can range from 0-108 with higher scores indicating better quality of life. | All available data were used for the linear contrasts. See Participant Flow for reasons for missing data. | Posted | Mean | Standard Error | score on a scale | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. |
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| Other Pre-specified | Coping | The Brief COPE measures adaptive coping. Range for each subscale (positive reframing, active coping, planning): 2-8; higher values indicate more adaptive coping. Subscales items are summed; no total score. | All available data were used for the linear contrasts. See Participant Flow for reasons for missing data. | Posted | Mean | Standard Error | score on a scale | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. |
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| Other Pre-specified | Goal Adjustment | Instrument name: Goal Disengagement and Goal Reengagement Scale (GDGRS). Range: 4 to 20 for goal disengagement and 6 to 30 for goal reengagement. Subscales: goal disengagement and goal reengagement (subscale items are averaged, no total score). Higher values indicate greater tendency to disengage or re-engage with goals. | All available data were used for the linear contrasts. See Participant Flow for reasons for missing data. | Posted | Mean | Standard Error | score on a scale | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. |
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| Other Pre-specified | Distress | Instrument name: Hospital Anxiety and Depression Scale (HADS). Range for each subscale (no total score): 0-21. Subscales: anxiety and depression. Higher values indicate greater anxiety and depression. | All available data were used for the linear contrasts. See Participant Flow for reasons for missing data. | Posted | Mean | Standard Error | score on a scale | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. |
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| Other Pre-specified | Occupational Performance | Instrument name: Canadian Occupational Performance Scale. The participant rates each activity with Likert scales for three characteristics: satisfaction (1- 10), performance (1-10), and importance (1 - 10). Interpretation: Higher values indicate higher occupational performance. | All available data were used for the linear contrasts. See Participant Flow for reasons for missing data. | Posted | Mean | Standard Error | score on a scale | The overall treatment effect will be computed as the between-group difference from Session 1 (baseline) and Session 9 (approximately week 20), estimated with a linear contrast. |
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| 0 |
| 144 |
| 0 |
| 144 |
| 0 |
| 144 |
| EG001 | Attention Control Condition | Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition). Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. | 0 | 140 | 0 | 140 | 0 | 140 |
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| Week 8 |
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| Week 20 |
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| Week 44 |
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| Week 8 |
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| Week 20 |
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| Week 44 |
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| Week 8 |
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| Week 20 |
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| Week 44 |
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| Overall score: Week 8 |
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| Overall score: Week 20 |
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| Overall score: Week 44 |
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| Physical subscale: Week 0 |
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| Physical subscale: Week 8 |
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| Physical subscale: Week 20 |
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| Physical subscale: Week 44 |
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| Social subscale: Week 0 |
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| Social subscale: Week 8 |
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| Social subscale: Week 20 |
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| Social subscale: Week 44 |
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| Emotional subscale: Week 0 |
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| Emotional subscale: Week 8 |
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| Emotional subscale: Week 20 |
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| Emotional subscale: Week 44 |
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| Functional subscale: Week 0 |
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| Functional subscale: Week 8 |
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| Functional subscale: Week 20 |
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| Functional subscale: Week 44 |
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| Active coping: Week 8 |
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| Active coping: Week 20 |
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| Active coping: Week 44 |
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| Planning: Week 0 |
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| Planning: Week 8 |
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| Planning: Week 20 |
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| Planning: Week 44 |
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| Positive reframing: Week 0 |
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| Positive reframing: Week 8 |
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| Positive reframing: Week 20 |
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| Positive reframing: Week 44 |
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| Disengagement: Week 8 |
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| Disengagement: Week 20 |
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| Disengagement: Week 44 |
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| Reengagement: Week 0 |
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| Reengagement: Week 8 |
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| Reengagement: Week 20 |
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| Reengagement: Week 44 |
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| Anxiety: Week 8 |
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| Anxiety: Week 20 |
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| Anxiety: Week 44 |
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| Depression: Week 0 |
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| Depression: Week 8 |
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| Depression: Week 20 |
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| Depression: Week 44 |
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| Importance: Session 9 (approximately week 20) |
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| Performance: Session 1 (baseline) |
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| Performance: Session 9 (approximately week 20) |
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| Satisfaction: Session 1 (baseline) |
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| Satisfaction: Session 9 (approximately week 20) |
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