Breast Cancer Clinical Trial
— IACS2Official title:
Developing an Integrative Intervention for Breast Cancer Survivorship
Verified date | March 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to conduct a randomized controlled trial or RCT of the following 2 supportive care interventions in recent breast cancer survivors: an Integrative Medicine intervention based on Ayurvedic medicine and a Health Education intervention.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 30, 2020 |
Est. primary completion date | February 6, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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: - Having received Ayurvedic treatment within 6 months of study enrollment - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco, Osher Center for Integrative Medicine | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in quality of life over 6 months | The investigators will use the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) in conjunction with a breast cancer-specific subscale, BR23, to collect data on qualify of life and cancer-related symptoms. The scales range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. The principle for scoring these scales is the same in all cases: Estimate the average of the items that contribute to the scale; this is the raw score. Use a linear transformation to standardise the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. |
Baseline, 3 months, 6 months | |
Secondary | Change in fatigue over 6 months | The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue. The scale ranges from 0 - 10. Scoring Instructions: To interpret it clinically, it is good to think about the lower 1/3 scores (0-3.2) being none or minimal fatigue, the middle 1/3 (3.3 to 6.6) being moderate fatigue, and the top 1/3 (6.7 to 10) being high fatigue. Energy Item Score: Mean of items 6-10 Fatigue Item Score: Mean of 1-5 and 11-18 |
Baseline, 3 months, 6 months | |
Secondary | Change in sleep quality over 6 months | The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance. The scale ranges from 0 (never) - 7 (Every Day) Reverse score items: 4, 10, 11, 12 (e.g., 0=7, 1=6, 2=5, 3=4, 4=3, 5=2, 6=1, 7=0). Scoring Instructions: Total Sum Score (gstot): Mean of all items * 21 (must have at least 16 items scored) Medications for Sleep Sum Score (gsmed): Mean of items 16-21 * 16 (must have at least 4) Quality of Sleep Sum Score (gsqal): Mean of items 4, 5, 10 * 3 (must have at least 2) Quantity of Sleep Sum Score (gsqnt): Mean of items 12, 13 * 2 (must have at least 2) Sleep Onset Latency (gsol): Item 1 Mid Sleep Wakes (gsmid): Item 2 Early Awakenings (gsend): Item 3 Excessive Daytime Sleepiness Sum Score (gseds): Mean of 6, 7, 8, 9, 11, 14, 15 * 7 (must have at least 5) |
Baseline, 3 months, 6 months | |
Secondary | Change in anxiety over 6 months | The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety. The scale ranges from 1 (Not at all) - 4 (Very much so) Reverse Scoring Items: 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 Outcome Variables: Scores range between 20-80 Total Sum Score (no missing values): Sum all questions Total Sum Score (few items missing): Average of the non-missing items and multiply by 20. |
Baseline, 3 months, 6 months | |
Secondary | Change in depressive symptoms over 6 months | The investigators will use the Center for Epidemiological Studies - Depression Scale (CES-D) to collect data on depressive symptoms. The scale ranges from 0 (Rarely) - 3 (Most Days) Reverse Scoring Items: 4, 8, 12, 16 Outcome Variables: Scores range between 0-60. If participant scores higher than 16, refer to guidelines for CES-D • Total Sum Score: Sum of 20 questions. Do not score if more than 4 missing answers. |
Baseline, 3 months, 6 months | |
Secondary | Change in pain over 6 months | The investigators will use the Brief Pain Inventory (BPI) to collect data on pain intensity and interference with function. | Baseline, 3 months, 6 months | |
Secondary | Change in diet over 6 months | The investigators will use the Automated Self-Administered 24-hour Recall (ASA24) to assess dietary recall over a 24 hour period. | Baseline, 3 months, 6 months |
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