Clinical trial NCT02897544: Integrative Approaches for Cancer Survivorship 2: Project 2
Official title: Developing a Health Education Intervention for Breast Cancer Survivorship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2016-09-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to develop and test a 6 month manualized Health Education intervention in recent breast cancer survivors.

Detailed description: Post-treatment cancer survivorship is often associated with a void in care given the drop-off in support provided to survivors from the medical team as well as family and friends. The investigators aim to develop and test a Health Education intervention in breast cancer survivors. Specifically, the investigators aim to develop the manualized Health Education intervention; to assess feasibility; and to provide preliminary data on the effects of the intervention. The data from this pilot study will be used to inform future study.

Eligibility criteria: Inclusion Criteria:

* Female breast cancer survivor who is over 1 month and less than 24 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy)
* Having received chemotherapy as part of their primary therapy for breast cancer
* Be in complete remission
* Aged 18 years or older
* Able to read, write, and understand English
* Karnofsky Performance Status (KPS) greater than or equal to 60
* Have impaired quality of life
* Ability to give informed consent

Exclusion Criteria:

* Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2 directed therapy is not exclusionary.
* Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary.
* Patients on adjuvant hormone therapy for less than 2 months
* Have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. Smaller surgical procedures such as implant exchange are not exclusionary.

Primary outcomes:
measure: Change in quality of life over 6 months
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Change in fatigue over 6 months
timeFrame: Baseline, 3 months, 6 months
measure: Change in sleep quality over 6 months
timeFrame: Baseline, 3 months, 6 months
measure: Change in anxiety over 6 months
timeFrame: Baseline, 3 months, 6 months
measure: Change in depressive symptoms over 6 months
timeFrame: Baseline, 3 months, 6 months
measure: Change in pain over 6 months
timeFrame: Baseline, 3 months, 6 months
measure: Change in diet over 6 months
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco, Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: University of California, San Francisco
name: Anand Dhruva, MD
role: PRINCIPAL_INVESTIGATOR
References: