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Behavioral Activation Therapy for Breast Cancer Survivors
N/A
Waitlist Available
Led By Kathleen Lyons, ScD, OTR
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age of 18 years or older
Experiencing reduced participation (i.e., a score greater than or equal to 10 on the Work and Social Adjustment Scale)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the overall treatment effect will be computed as the between-group difference in change from baseline (change from baseline averaged over weeks 8, 20, and 44) estimated with a linear contrast.
Awards & highlights
Study Summary
This trial tests whether a BA/PS approach can help improve activity participation for breast cancer survivors after treatment.
Who is the study for?
This trial is for female breast cancer survivors, aged 18 or older, who have completed treatment within the past year and are experiencing reduced activity. They must not have disease recurrence, severe mental illness, current major depression, suicidal thoughts, substance misuse issues, cognitive impairments or non-correctable hearing loss.Check my eligibility
What is being tested?
The study compares a Behavioral Activation/Problem Solving (BA/PS) approach with an attention control condition to see which is better at improving activity participation among 300 breast cancer survivors who've reported decreased activity after treatment.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, traditional side effects like those seen with drugs are not expected. Participants may experience emotional discomfort when discussing personal experiences related to their cancer journey.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My health issues are affecting my work or social life.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the overall treatment effect will be computed as the between-group difference in change from baseline (change from baseline averaged over weeks 8, 20, and 44) estimated with a linear contrast.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the overall treatment effect will be computed as the between-group difference in change from baseline (change from baseline averaged over weeks 8, 20, and 44) estimated with a linear contrast.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Participation ability in social roles and activities
Change in Participation satisfaction in social roles and activities: PROMIS
Change in productivity
+1 moreSecondary outcome measures
Change in Quality of life: Functional Assessment of Cancer Therapy- (FACT-G)
Other outcome measures
Change in Distress
Change in Goal adjustment
Change in Occupational Performance
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: The Behavioral Activation/ Problem Solving InterventionExperimental Treatment1 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.
Group II: Attention Control ConditionActive Control1 Intervention
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).
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Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,543,039 Total Patients Enrolled
29 Trials studying Breast Cancer
2,352,830 Patients Enrolled for Breast Cancer
MGH Institute of Health ProfessionsLead Sponsor
15 Previous Clinical Trials
3,355 Total Patients Enrolled
1 Trials studying Breast Cancer
40 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,925,866 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment open for this medical experiment at the present time?
"According to clinicaltrials.gov, this healthcare project is no longer recruiting participants. Initially posted on August 28th 2019 and last updated June 16th 2022, the investigation has closed its recruitment window - however 2301 other trials are presently seeking applicants."
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