Participation Restrictions in Breast Cancer Survivors
|ClinicalTrials.gov Identifier: NCT01225328|
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : December 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Behavioral activation/problem-solving (BA/PS)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Participation Restrictions in Young-Middle Adult Rural Breast Cancer Survivors|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Telephone-delivered Behavioral Activation/Problem Solving (BA/PS) intervention
Behavioral: Behavioral activation/problem-solving (BA/PS)
Six weekly telephone sessions to train participant in BA/PS procedures
- Feasibility [ Time Frame: six weeks ]
- of patients evaluated for enrollment / # of patients approached.
- of patients meeting eligibility criteria / # of patients evaluated.
- of patients enrolled / # of patients meeting eligibility criteria
- of patients completing 6 weeks of BA/PS treatment.
- of patients completing each study assessment point (T1, T2, T3, T4).
- Functional status [ Time Frame: baseline, six weeks, 12 weeks, 18 weeks ]The Medical Outcomes Short Form-36 (MOS SF-36) consists of eight scales (physical functioning, role limitations - physical, role limitations - emotional, vitality, well being, social functioning, bodily pain, and general health) and two standardized component summary scores (physical and mental). The physical and mental factors account for 80-85% of the variance in the scales. We will use the Physical Component Summary (PCS) Score as the primary outcome measure.
- Quality of life [ Time Frame: baseline, six weeks, 12 weeks, 18 weeks ]The Functional Assessment of Cancer Therapy-Breast Cancer + Arm Morbidity (FACT-B+4) is a 41-item self-report measure of health-related quality of life specifically designed for breast cancer patients.
- Affective symptoms [ Time Frame: baseline, six weeks, 12 weeks, 18 weeks ]The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report measure of depressive and anxiety symptoms specifically designed for medical patients. The HADS contains only the cognitive symptoms of depression and anxiety, thus eliminating the somatic symptoms that are poor indicators of psychiatric distress in the medically ill.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225328
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Mark T Hegel, PhD||Dartmouth-Hitchcock Medical Center|