Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to evaluate whether self-management discussion groups are helpful for women with advanced breast cancer who are experiencing pain. The study is looking at the usefulness of two different types of discussion groups, one of which also includes gentle exercise.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| discussion group | Active Comparator | Eight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain |
|
| discussion group + exercise | Active Comparator | Eight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain and learn gentle exercise and breathing techniques |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| discussion group | Behavioral | Participants engage in discussions regarding issues related to coping with advanced cancer and pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Feasibility will be indicated by our ability to meet accrual goals, and by at least 70% of patients attending ≥4 of 8 sessions and providing post-test assessments | 36 months |
| Acceptability | Acceptability will be assessed via participant ratings on a standardized measure of treatment effectiveness/satisfaction, supplemented by exit interview | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain | pain intensity as assessed by the Brief Pain Inventory | study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months |
| Change in fatigue |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laura Porter, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27708 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28288595 | Derived | Carson JW, Carson KM, Olsen MK, Sanders L, Porter LS. Mindful Yoga for women with metastatic breast cancer: design of a randomized controlled trial. BMC Complement Altern Med. 2017 Mar 13;17(1):153. doi: 10.1186/s12906-017-1672-9. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| gentle exercise | Behavioral | Patients learn gentle exercise and breathing techniques |
|
Fatigue as assessed by the Brief Fatigue Inventory
| study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months |
| Change in sleep disturbance | Sleep disturbance as assessed by the Pittsburgh Sleep Quality Index | study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months |
| Change in Psychological distress | Anxiety and depression assessed using the Hospital Anxiety and Depression Scale | study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months |
| Change in functional capacity | Functional capacity assessed using a 6-minute walk test | study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months |