Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 11/28/2018 |
| Start Date: | October 2015 |
| End Date: | September 2019 |
The objective of the study is to develop and test the feasibility, acceptability, and initial
efficacy of a novel couples-based behavioral weight and symptom management intervention for
obese breast cancer survivors and their partners. The proposed project consists of two
phases. Phase I will include intervention development and refinement. Intervention
development will be guided by the research team's prior work, the interdependence model of
communal coping and behavior change, and information obtained from couples participating in
focus groups. The intervention protocol will then be tested with 5 couples to assist with
refinement of intervention content. During phase II, the feasibility, acceptability and
initial efficacy of the intervention will be examined. Obese breast cancer survivors in the
three years following treatment and their overweight or obese partners will receive 6 weekly
and 6 biweekly sessions for a total of 12 sessions spaced across approximately 5 months. The
intervention will be provided in a couples-based format where each couple will meet
separately with the therapist. Couples will be assessed at pre-, post-, and 3-months
post-treatment. Study outcomes will be weight, symptoms (i.e., pain, fatigue, distress),
eating behavior, and physical activity. Exploratory outcomes examine biomarkers (i.e.,
insulin, IL-6, IL-8, TNF-alpha, adiponectin) associated with health outcomes for cancer
survivors and their partners. It is hypothesized that the intervention will be feasible
(i.e., completed sessions), and participants will find the intervention acceptable as
assessed by a measure of treatment acceptability. It is also hypothesized that participants
will evidence decreased weight and improvements in symptoms (i.e., pain, fatigue, distress),
eating behavior, and physical activity, and their change in weight will covary with change in
symptoms, eating behavior, and daily physical activity. Finally, it is hypothesized that
participants with greater weight loss will evidence improved functioning in insulin, IL-6,
IL-8, TNF-α, adiponectin, and heart rate.
efficacy of a novel couples-based behavioral weight and symptom management intervention for
obese breast cancer survivors and their partners. The proposed project consists of two
phases. Phase I will include intervention development and refinement. Intervention
development will be guided by the research team's prior work, the interdependence model of
communal coping and behavior change, and information obtained from couples participating in
focus groups. The intervention protocol will then be tested with 5 couples to assist with
refinement of intervention content. During phase II, the feasibility, acceptability and
initial efficacy of the intervention will be examined. Obese breast cancer survivors in the
three years following treatment and their overweight or obese partners will receive 6 weekly
and 6 biweekly sessions for a total of 12 sessions spaced across approximately 5 months. The
intervention will be provided in a couples-based format where each couple will meet
separately with the therapist. Couples will be assessed at pre-, post-, and 3-months
post-treatment. Study outcomes will be weight, symptoms (i.e., pain, fatigue, distress),
eating behavior, and physical activity. Exploratory outcomes examine biomarkers (i.e.,
insulin, IL-6, IL-8, TNF-alpha, adiponectin) associated with health outcomes for cancer
survivors and their partners. It is hypothesized that the intervention will be feasible
(i.e., completed sessions), and participants will find the intervention acceptable as
assessed by a measure of treatment acceptability. It is also hypothesized that participants
will evidence decreased weight and improvements in symptoms (i.e., pain, fatigue, distress),
eating behavior, and physical activity, and their change in weight will covary with change in
symptoms, eating behavior, and daily physical activity. Finally, it is hypothesized that
participants with greater weight loss will evidence improved functioning in insulin, IL-6,
IL-8, TNF-α, adiponectin, and heart rate.
Phase I: Intervention Development and Refinement:
Inclusion Criteria:
- Patients:
- Female,
- obese (BMI >30)
- partnered
- diagnosis of non-metastatic breast cancer (stages I-III)
- completed adjuvant chemotherapy and/or radiation treatment in the last 5 years
- healthy enough to participate in a home-based walking program (if participating
in intervention refinement),
- able to speak English
- able and willing to give informed consent.
- Partners:
- Overweight/obese (BMI >25)
- cohabiting partner of a woman with non-metastatic breast cancer completing
adjuvant chemotherapy and/or radiation in the last 5 years
- healthy enough to participate in a home-based walking program (if participating
in intervention refinement)
- able to speak English
- able and willing to give informed consent.
Exclusion Criteria: for both patients and partners
- male breast cancer survivors
- non-ambulatory
- unable to provide informed consent
- have a major mental illness (i.e., schizophrenia);
- have a mental illness that is not being treated/controlled (i.e., bipolar disorder)
- reside > 100 miles from the research site.
Phase II: Feasibility, Acceptability, and Efficacy of the Intervention
Inclusion Criteria:
- Patients:
- Female, obese (BMI >30)
- partnered
- diagnosis of non-metastatic breast cancer (stages I-III)
- completed adjuvant chemotherapy and/or radiation treatment in the last 3 years
- healthy enough to participate in a home-based walking program
- able to speak English
- able and willing to give informed consent.
- Partners:
- Overweight/obese (BMI >25)
- cohabiting partner of a woman with non-metastatic breast cancer completing
adjuvant chemotherapy and/or radiation in the three years
- healthy enough to participate in a home-based walking program
- able to speak English
- able and willing to give informed consent.
Exclusion Criteria: for both patients and partners
- male breast cancer survivors
- non-ambulatory
- unable to provide informed consent
- have a major mental illness (i.e., schizophrenia)
- have a mental illness that is not being treated/controlled (i.e., bipolar disorder)
- reside > 100 miles from the research site.
- Pregnant women will also be excluded from the study.
We found this trial at
1
site
20 Duke Clinic Cir
Durham, North Carolina 27710
Durham, North Carolina 27710
(888) 275-3853
Principal Investigator: Caroline S Dorfman, PhD
Phone: 919-416-3473
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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