Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01CA230542 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Eskenazi Health | OTHER |
| Community Health Network | OTHER |
| Indiana University Health |
Not provided
Not provided
Not provided
Not provided
This trial tests telephone-based Acceptance and Commitment Therapy (ACT), a type of psychotherapy, to reduce fatigue interference with activities, mood, and cognition in metastatic breast cancer (MBC) cancer patients. ACT includes mindfulness exercises (e.g., meditations, performing activities with greater awareness), identifying personal values (e.g., family, work), and engaging in activities consistent with these values. A total of 250 patients will be randomly assigned in equal numbers to either the ACT intervention or an education/support condition. Patients in both conditions will participate in six weekly 50-minute telephone sessions. Outcomes will be assessed at baseline, 2 weeks post-intervention, and 3 and 6 months post-intervention. The investigators hypothesize that ACT will lead to improved primary and secondary outcomes as compared to education/support. A demonstration of ACT's efficacy will lead to dissemination of the intervention and ultimately fulfill an unmet need in the comprehensive care of MBC patients.
This trial tests the effect of telephone-based Acceptance and Commitment Therapy (ACT) on fatigue interference in metastatic breast cancer (MBC) patients (Aim 1) as well as secondary outcomes (Aim 2). This trial also examines increases in psychological flexibility as a hypothesized mediator of ACT's effect on fatigue interference (Aim 3). Finally, two core aspects of psychological flexibility (i.e., mindfulness/acceptance and commitment/behavior change processes) are examined as exploratory mediators of ACT's effect on fatigue interference. The study team will recruit MBC patients receiving care through Eskenazi Health or Indiana University (IU) Health. Potentially eligible patients will be mailed an introductory letter signed by their oncologist and the PI along with a consent form. The letter will have a number to call if they do not wish to be contacted further. A research assistant (RA) will call all prospective participants who do not opt out approximately 1 to 2 weeks after the letter is mailed. The RA will describe the study as outlined in the consent form and answer any questions. Then the RA will administer an eligibility screening to those who consent to participate. Eligible and consenting patients will complete a 35-minute baseline phone assessment. Following baseline assessments, MBC patients (N = 250) will be randomly assigned in equal numbers to ACT or education/support using a stratified block randomization scheme to balance the groups by age (<65 yrs. vs. 65+ yrs.) and performance status (patient-reported Eastern Cooperative Oncology Group [ECOG] scores 0 or 1 vs. 2). Patients in both study conditions will complete six weekly 50-minute telephone sessions with the first session occurring one week after baseline. For ACT participants, adherence to home practice during the past week will be assessed and recorded during each session. Blind interviewers will assess outcomes and potential mediators during 30-minute follow-up phone assessments at 2 weeks, 3 months, and 6 months post-intervention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue. |
|
| Education/Support | Active Comparator | Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Behavioral | Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Interference Subscale of Fatigue Symptom Inventory | Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome. | 2 weeks, 3 months, and 6 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment | This 8-item measure assesses the perceived interference of sleep problems with activities, mood, and cognition (e.g., difficulty concentrating or completing tasks). Each item is rated on a scale from 1 (not at all) to 5 (very much). Item #2 is reverse-scored and then the 8 items are summed with higher total scores indicating greater sleep-related impairment. The total scores are converted to T-scores with a range from 30.0 to 80.1. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Catherine E Mosher, Ph.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois | 60611 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39454125 | Derived | Mosher CE, Lee S, Addington EL, Park S, Lewson AB, Snyder S, Hirsh AT, Bricker JB, Miller KD, Ballinger TJ, Schneider BP, Storniolo AM, Newton EV, Champion VL, Johns SA. Randomized Controlled Trial of Acceptance and Commitment Therapy for Fatigue Interference With Functioning in Metastatic Breast Cancer. J Clin Oncol. 2025 Feb 20;43(6):662-671. doi: 10.1200/JCO.24.00965. Epub 2024 Oct 25. |
Not provided
Not provided
Results of this trial will be presented at professional meetings and published in peer-reviewed journals. The data set will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. The data set will contain necessary identifiers, excluding those prohibited by HIPAA. The investigators will be required to sign a data use agreement and obtain Institutional Review Board (IRB) approval before receiving the data set.
The data set will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. Data will be available for at least 6 years.
The data set and supporting information will be made available to qualified investigators to allow replication of analyses or secondary data analyses. The PI will review requests for data access. The investigators will be required to sign a data use agreement and obtain IRB approval before receiving the data set. The mechanism for data sharing will be reviewed by the IRB.
Not provided
14 patients were excluded from the study before assignment to groups. Here is a list of the reasons:
Not feeling well/health problems (2), Did not have time (5), Participation was too much work (4), Not interested in the study (1), Not eligible (1), Other (1)
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Acceptance and Commitment Therapy | Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue. Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices. |
| FG001 | Education/Support | Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community. Education/Support: Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Acceptance and Commitment Therapy | Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue. Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices. |
| 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 | Fatigue Interference Subscale of Fatigue Symptom Inventory | Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks, 3 months, and 6 months post-intervention |
|
Adverse event data were collected on each participant from the point of baseline until approximately 8 months post-baseline.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acceptance and Commitment Therapy | Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue. Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deaths | General disorders | Non-systematic Assessment | All patients had advanced cancer at the time of enrollment and the serious adverse events (deaths) were expected and unrelated to the study intervention. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Catherine Mosher | Indiana University | 317-274-6769 | cemosher@iu.edu |
Not provided
| 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 | Aug 20, 2024 | Sep 11, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 4, 2021 | May 10, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| D004522 | Educational Status |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
| OTHER |
| Northwestern University | OTHER |
Metastatic breast cancer patients (N = 250) will be randomly assigned in equal numbers to Acceptance and Commitment Therapy (ACT) or education/support using a stratified block randomization scheme to balance the groups by age (<65 yrs. vs. 65+ yrs.) and performance status (patient-reported Eastern Cooperative Oncology Group [ECOG] scores 0 or 1 vs. 2).
Not provided
Not provided
Not provided
|
| Education/Support | Behavioral | Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework. |
|
| 2 weeks, 3 months, and 6 months post-intervention |
| PROMIS Ability to Participate in Social Roles and Activities | This 6-item measure assesses participants' ability to participate in social roles and activities. The items measure difficulty engaging in social and recreational activities as well as usual work (including housework). Each item is rated on a scale from 1 (never) to 5 (always) and is reverse coded. Then the six items are summed with higher total scores indicating greater ability to participate in social roles and activities. The total scores are converted to T-scores with a range from 26.7 to 65.0 with higher scores indicating a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome. | 2 weeks, 3 months, and 6 months post-intervention |
| Functional Assessment of Cancer Therapy-General | This 27-item measure evaluates physical, social/family, emotional, and functional quality of life. For each of the 4 subscale scores (i.e., Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being), the items are summed, multiplied by the number of items, and divided by the number of items answered, with higher scores indicating better quality of life. Items are rated on 0 to 4 scales. The physical well-being subscale is the sum of 7 items (all items reverse-coded) with a range of 0 to 28. The social/family well-being subscale is the sum of 7 items (none reverse-coded) with a range of 0 to 28. The emotional well-being subscale is the sum of 6 items (5 items reverse-coded) with a range of 0 to 24. The functional well-being subscale is the sum of 7 items (none reverse-coded) with a range of 0 to 28. This is a secondary outcome measure. | 2 weeks, 3 months, and 6 months post-intervention |
| Indiana University Simon Comprehensive Cancer Center |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Community Health Network | Indianapolis | Indiana | 46256 | United States |
| Not feeling well/health problems |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG001 | Education/Support | Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community. Education/Support: Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | 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 |
|
| Household income | Income data were collected in categories. | Count of Participants | Participants |
|
| Years of education | Years of education | Mean | Standard Deviation | years |
|
| Time since stage IV breast cancer diagnosis | Collected from patient medical records at baseline | Mean | Standard Deviation | years |
|
| Chemotherapy | Collected from patient medical records at baseline | Count of Participants | Participants |
|
| Radiation | Collected from patient medical records at baseline | Count of Participants | Participants |
|
| Hormonal Therapy | Collected from patient medical records at baseline | Count of Participants | Participants |
|
| Targeted Therapy | Collected from patient medical records at baseline | Count of Participants | Participants |
|
| OG001 | Education/Support | Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community. Education/Support: Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework. |
|
|
|
| Secondary | Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment | This 8-item measure assesses the perceived interference of sleep problems with activities, mood, and cognition (e.g., difficulty concentrating or completing tasks). Each item is rated on a scale from 1 (not at all) to 5 (very much). Item #2 is reverse-scored and then the 8 items are summed with higher total scores indicating greater sleep-related impairment. The total scores are converted to T-scores with a range from 30.0 to 80.1. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome. | Posted | Mean | Standard Deviation | T-score | 2 weeks, 3 months, and 6 months post-intervention |
|
|
|
|
| Secondary | PROMIS Ability to Participate in Social Roles and Activities | This 6-item measure assesses participants' ability to participate in social roles and activities. The items measure difficulty engaging in social and recreational activities as well as usual work (including housework). Each item is rated on a scale from 1 (never) to 5 (always) and is reverse coded. Then the six items are summed with higher total scores indicating greater ability to participate in social roles and activities. The total scores are converted to T-scores with a range from 26.7 to 65.0 with higher scores indicating a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome. | Posted | Mean | Standard Deviation | T-score | 2 weeks, 3 months, and 6 months post-intervention |
|
|
|
|
| Secondary | Functional Assessment of Cancer Therapy-General | This 27-item measure evaluates physical, social/family, emotional, and functional quality of life. For each of the 4 subscale scores (i.e., Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being), the items are summed, multiplied by the number of items, and divided by the number of items answered, with higher scores indicating better quality of life. Items are rated on 0 to 4 scales. The physical well-being subscale is the sum of 7 items (all items reverse-coded) with a range of 0 to 28. The social/family well-being subscale is the sum of 7 items (none reverse-coded) with a range of 0 to 28. The emotional well-being subscale is the sum of 6 items (5 items reverse-coded) with a range of 0 to 24. The functional well-being subscale is the sum of 7 items (none reverse-coded) with a range of 0 to 28. This is a secondary outcome measure. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks, 3 months, and 6 months post-intervention |
|
|
|
|
| 7 |
| 116 |
| 7 |
| 116 |
| 0 |
| 116 |
| EG001 | Education/Support | Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community. Education/Support: Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework. | 11 | 120 | 11 | 120 | 0 | 120 |
|
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Sleep-related impairment at 6 months post-intervention |
|
| Ability to participate in social roles and activities at 6 months post-intervention |
|
| Physical quality of life at 6 months post-intervention |
|
| Social/family quality of life at 2 weeks post-intervention |
|
| Social/family quality of life at 3 months post-intervention |
|
| Social/family quality of life at 6 months post-intervention |
|
| Emotional quality of life at 2 weeks post-intervention |
|
| Emotional quality of life at 3 months post-intervention |
|
| Emotional quality of life at 6 months post-intervention |
|
| Functional quality of life at 2 weeks post-intervention |
|
| Functional quality of life at 3 months post-intervention |
|
| Functional quality of life at 6 months post-intervention |
|
| Mixed Models Analysis |
degrees of freedom = 234. Multiply imputed data were used. |
| .105 |
P-value for study group x time interaction for social/family quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085). |
| partial correlation |
| 0.09 |
| 2-Sided |
| 95 |
| -0.03 |
| 0.22 |
| Superiority |
| Mixed Models Analysis | degrees of freedom = 234. Multiply imputed data were used. | .142 | P-value for study group x time interaction for emotional quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085). | partial correlation | 0.09 | 2-Sided | 95 | -0.04 | 0.22 | Superiority |
| Mixed Models Analysis | degrees of freedom = 234. Multiply imputed data were used. | .006 | P-value for study group x time interaction for functional quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085). | partial correlation | 0.13 | 2-Sided | 95 | 0.01 | 0.26 | Superiority |