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The purpose of this study is to test preliminary efficacy, as well as acceptability and feasibility, of a dyadic exercise intervention, the current study will randomize LGBT cancer survivors and their non-professional caregivers as dyads to either an individual or a dyadic Exercise for Cancer Patients (EXCAP) intervention. The primary outcome assessed will be psychological distress. Analyses will involve pre-post comparisons of outcomes across the study arms, testing the hypothesis that a 6 week, daily, dyadic exercise intervention will result in greater improvements in psychological distress than an individual intervention.
The proposed randomized controlled trial aims to recruit 70 lesbian, gay, bisexual, and transgender (LGBT) cancer survivors who have completed treatment (surgery, radiation, or chemotherapy) within the past 24 months, so as to have a final, evaluable sample of 60 LGBT survivors after attrition. The proposed RCT will also recruit caregivers (broadly defined) of the above cancer survivors. Each recruited cancer survivor will be asked to name a person who they feel provided care (emotional, informational, tangible, etc.) during their cancer experience, with no further strictures placed on this relationship in terms of type or duration. The caregiver will be approached to participate in the RCT. Thus the sample will consist of 70 LGBT survivors (60 evaluable) and their caregivers (140 individuals total/120 evaluable). Recruitment and primary analyses will specifically target the LGBT cancer survivor.
All data will be gathered from participants 21 years of age or older. Participants are cancer survivors who have completed treatments or caregivers of cancer survivors; both survivors and caregivers are able to read and understand English.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dyadic Exercise Intervention | Active Comparator | Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivor and caregiver are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. |
|
| Individual Exercise Intervention | Other | Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise for Cancer Patients | Behavioral | a standardized, daily, 6 week, home-based, progressive exercise program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Psychological Distress | Self-reported psychological distress was measured with the Profile of Mood States (POMS) total score among LGBT cancer survivors. The POMS consists of 30 adjectives that subjects rate on a five-point scale with "1" = "Not at all" and "5" = "Extremely" to describe their moods over the past week. The total score can be calculated by adding the raw scores from tension, depression, anger, fatigue and confusion-focused items and then subtracting the vigour-focused items. This will give a value between -24 and 177, with higher scores indicating higher psychological distress. | Assessed at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Biological Endpoints: Cortisol | The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: serum cortisol among LGBT cancer survivors. | Assessed at 8 weeks |
| Biological Endpoints: Serum Amyloid A |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Distress Among Caregivers | Self-reported psychological distress among caregivers of LGBT cancer survivors was determined using the Profile of Mood States (POMS) total score. The POMS consists of 30 adjectives that subjects rate on a five-point scale with "1" = "Not at all" and "5" = "Extremely" to describe their moods over the past week. The total score can be calculated by adding the raw scores from tension, depression, anger, fatigue and confusion-focused items and then subtracting the vigour-focused items. This will give a value between -24 and 177, with higher scores indicating higher psychological distress. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Kamen, PhD, MPH | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dyadic Exercise Intervention for LGBT Survivors | Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program |
| FG001 | Individual Exercise Intervention for LGBT Cancer Survivors | Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program |
| FG002 | Dyadic Exercise Intervention for Caregivers | Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program |
| FG003 | Individual Caregivers-No Intervention | A caregiver is defined as any individual whom the cancer survivor nominates as having provided emotional support or tangible assistance without pay during the survivor's cancer experience. No restriction will be placed on caregivers in terms of relationship with the cancer survivor; they can be family members, friends, romantic partners, or community members |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The above number reflects participants who completed at least the baseline study visit. The number differs from the previous page total as anyone who consented was counted towards the total enrollment number.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dyadic Exercise Intervention for LGBT Cancer Survivors | Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program |
| 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 | Self-Reported Psychological Distress | Self-reported psychological distress was measured with the Profile of Mood States (POMS) total score among LGBT cancer survivors. The POMS consists of 30 adjectives that subjects rate on a five-point scale with "1" = "Not at all" and "5" = "Extremely" to describe their moods over the past week. The total score can be calculated by adding the raw scores from tension, depression, anger, fatigue and confusion-focused items and then subtracting the vigour-focused items. This will give a value between -24 and 177, with higher scores indicating higher psychological distress. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 8 weeks |
|
8 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 | Dyadic Exercise Intervention for LGBT Cancer Survivors | Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious Adverse Event | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Kamen, PhD | University of Rochester | 585-275-9958 | charles_Kamen@urmc.rochester.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 | Jul 6, 2020 | Nov 16, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 16, 2020 | Nov 16, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: markers of early inflammation serum amyloid A (SAA) among LGBT cancer survivors. |
| Assessed at 8 weeks |
| Biological Endpoints: C-reactive Protein | The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: markers of C-reactive protein (CRP) among LGBT cancer survivors. | Assessed at 8 weeks |
| Mechanistic Outcomes: Support | Social support from the care partner was measured with the Dyadic Support Questionnaire (DSQ) among LGBT cancer survivors. The DSQ is an 18-item survey based on four functions of social support (emotional, appraisal, instrumental, and informational support). Nine items measure received social support, that is, support provided by the partner. Items are anchored using a Likert scale ranging from 1 to 5 (from not at all to a great deal). Items were summed to create a scale for received support ranging from 9-45, with higher scores indicating more support. | Assessed at 8 weeks |
| Mechanistic Outcomes: Adherence | We also aim to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on social support from the care partners intervention adherence (actigraphy) among LGBT cancer survivors. The actigraph features a variable epoch length which can be set between 1 to 240 seconds. Software supplied by the manufacturer was used to determine number of minutes of moderate or higher activity during each assessment period. | Assessed at 8 weeks |
| Assessed at 8 weeks |
| Biological Endpoints of Distress Among Caregivers | An exploratory aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress among caregivers of LGBT cancer survivors: serum cortisol. | Assessed at 8 weeks |
| Lost to Follow-up |
|
| BG001 | Individual Exercise Intervention for LGBT Cancer Survivors | Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program |
| BG002 | Dyadic Exercise Intervention for Caregivers | Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program |
| BG003 | Individual Caregivers-No Intervention | A caregiver is defined as any individual whom the cancer survivor nominates as having provided emotional support or tangible assistance without pay during the survivor's cancer experience. No restriction will be placed on caregivers in terms of relationship with the cancer survivor; they can be family members, friends, romantic partners, or community members |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| OG001 | Individual Exercise Intervention for LGBT Cancer Survivors | Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program |
|
|
| Secondary | Biological Endpoints: Cortisol | The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: serum cortisol among LGBT cancer survivors. | Note that only 30 LGBT survivors from the Dyadic Exercise Intervention and only 27 from the Individual Exercise intervention had analyzable blood, which is why the total number of participants differs from other outcome measures. | Posted | Mean | Standard Deviation | ng/ml | Assessed at 8 weeks |
|
|
|
| Secondary | Biological Endpoints: Serum Amyloid A | The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: markers of early inflammation serum amyloid A (SAA) among LGBT cancer survivors. | Note that only 30 LGBT survivors from the Dyadic Exercise Intervention and only 27 from the Individual Exercise intervention had analyzable blood, which is why the total number of participants differs from other outcome measures. | Posted | Mean | Standard Deviation | ng/ml | Assessed at 8 weeks |
|
|
|
| Secondary | Biological Endpoints: C-reactive Protein | The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: markers of C-reactive protein (CRP) among LGBT cancer survivors. | Note that only 30 LGBT survivors from the Dyadic Exercise Intervention and only 27 from the Individual Exercise intervention had analyzable blood, which is why the total number of participants differs from other outcome measures. | Posted | Mean | Standard Deviation | pg/ml | Assessed at 8 weeks |
|
|
|
| Secondary | Mechanistic Outcomes: Support | Social support from the care partner was measured with the Dyadic Support Questionnaire (DSQ) among LGBT cancer survivors. The DSQ is an 18-item survey based on four functions of social support (emotional, appraisal, instrumental, and informational support). Nine items measure received social support, that is, support provided by the partner. Items are anchored using a Likert scale ranging from 1 to 5 (from not at all to a great deal). Items were summed to create a scale for received support ranging from 9-45, with higher scores indicating more support. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 8 weeks |
|
|
|
| Secondary | Mechanistic Outcomes: Adherence | We also aim to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on social support from the care partners intervention adherence (actigraphy) among LGBT cancer survivors. The actigraph features a variable epoch length which can be set between 1 to 240 seconds. Software supplied by the manufacturer was used to determine number of minutes of moderate or higher activity during each assessment period. | Posted | Mean | Standard Deviation | minutes per day | Assessed at 8 weeks |
|
|
|
| Other Pre-specified | Self-Reported Distress Among Caregivers | Self-reported psychological distress among caregivers of LGBT cancer survivors was determined using the Profile of Mood States (POMS) total score. The POMS consists of 30 adjectives that subjects rate on a five-point scale with "1" = "Not at all" and "5" = "Extremely" to describe their moods over the past week. The total score can be calculated by adding the raw scores from tension, depression, anger, fatigue and confusion-focused items and then subtracting the vigour-focused items. This will give a value between -24 and 177, with higher scores indicating higher psychological distress. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 8 weeks |
|
|
|
| Other Pre-specified | Biological Endpoints of Distress Among Caregivers | An exploratory aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress among caregivers of LGBT cancer survivors: serum cortisol. | Note that only 30 caregivers from the Dyadic Exercise Intervention and only 27 from the Individual Exercise intervention had analyzable blood, which is why the total number of participants differs from other outcome measures. | Posted | Mean | Standard Deviation | ng/ml | Assessed at 8 weeks |
|
|
|
| 3 |
| 32 |
| 1 |
| 32 |
| 0 |
| 32 |
| EG001 | Individual Exercise Intervention for LGBT Cancer Survivors | Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program | 2 | 31 | 0 | 31 | 0 | 31 |
| EG002 | Dyadic Exercise Intervention for Caregivers | Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivors and caregivers are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program | 1 | 32 | 0 | 32 | 0 | 32 |
| EG003 | Individual Caregivers-No Intervention | A caregiver is defined as any individual whom the cancer survivor nominates as having provided emotional support or tangible assistance without pay during the survivor's cancer experience. No restriction will be placed on caregivers in terms of relationship with the cancer survivor; they can be family members, friends, romantic partners, or community members | 1 | 31 | 0 | 31 | 0 | 31 |
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