Integrative Approaches for Cancer Survivorship: A Multi-Site Feasibility and Acceptability Study (Aim 2)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 107
- 试验地点
- 4
- 主要终点
- Proportion of all screened participants who were ultimately enrolled
研究概览
简要总结
This clinical trial is a two-arm pilot randomized controlled trial for non-metastatic breast cancer survivors to determine the feasibility, acceptability, and fidelity of two integrative health approaches and study design in a multi-site setting. Participants (n=104) will be randomized to either the Ayurveda Intervention (AVI) or Facing Forward Health Education Intervention (FFHEI). Integrative health combines biomedical and complementary approaches together in a coordinated way. AVI, a multi-modal intervention, includes nutritional education, lifestyle practices, yoga, and therapeutic touch, called marma, to help the body and mind feel balanced. FFHEI provides health education using self-directed online content and interactive videos based on the latest science in cancer survivorship. This study does not intend to conduct tests of efficacy and is focused on feasibility outcomes.
详细描述
PRIMARY OBJECTIVES
I. Determine feasibility and acceptability of this design in a multi-site setting.
SECONDARY OBJECTIVES
I. Evaluate Quality of Life (QOL).
II. Evaluate Cancer Associated Symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be masked to the study hypothesis. Research staff involved with data analysis will be blinded to group assignment until the database is locked. The statistician will remain blinded until the completion of the analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand study procedures and to comply with them for the entire length of the study.
- •Able to read, write, and understand English.
- •Ability of individual or legal guardian/representative to understand a verbal informed consent document, and the willingness to sign it.
- •Non-metastatic breast cancer patients who are between 1 and 36 months after completion of primary treatment (i.e., surgery, radiotherapy, chemotherapy) and are in a complete remission.
- •Participants should have received chemotherapy as part of their primary treatment.
- •Have an impaired quality of life (report a score of 5 or less on question 30 of the European Organisation for Research and Treatment of Cancer Quality of Life Cancer questionnaire (EORTC-QLQ-C30). "How would you rate your overall quality of life during the past week?"
- •Karnofsky Performance Status Score (KPS) >=60
- •Ayurveda Practitioners
- •1. Must be engaged as an Ayurvedic Intervention practitioner on the Renew study
排除标准
- •Contraindication to any study-related procedure or assessment.
- •Metastatic disease and receiving chemotherapy or radiotherapy at the time of study enrollment (participants with non-metastatic disease who are receiving anti-Her2 directed treatment alone in the adjuvant setting are eligible).
- •Participants are within 1 month after surgery for cancer, including breast reconstructive surgery but not including implant exchange.
- •Cancer surgery planned during the initial 6-month study period.
- •Been on adjuvant hormone therapy (for breast cancer) less than 2 months at the time of enrollment.
- •Received Ayurvedic treatment during the 3 months preceding enrollment.
- •If a participant reports severe anxiety or depression, has severe depression assessed by Patient Health Questionnaire (PHQ)-9 using a cut-off of 20 or higher, or severe anxiety assessed by the General Anxiety Disorder-7 (GAD-7) using a cut-off 15 or higher.
- •Current suicidal ideation.
- •Ayurveda Practitioners
研究组 & 干预措施
Ayurveda and Usual Care (AVI)
Participants receive usual care on study. Participants also receive nutrition education, lifestyle recommendations, and participate in yoga, as well as marma therapeutic touch during one-on-one AVI visits over 1-2 hours for up to 14 visits over 6 months. After 6 months, participants may also complete a videoconference visit over 30 minutes once monthly for 6 months. In addition, participants will complete online questionnaires at baseline and at the end of 6 months.
干预措施: Marma therapy (Procedure)
Ayurveda and Usual Care (AVI)
Participants receive usual care on study. Participants also receive nutrition education, lifestyle recommendations, and participate in yoga, as well as marma therapeutic touch during one-on-one AVI visits over 1-2 hours for up to 14 visits over 6 months. After 6 months, participants may also complete a videoconference visit over 30 minutes once monthly for 6 months. In addition, participants will complete online questionnaires at baseline and at the end of 6 months.
干预措施: Nutrition Education (Behavioral)
Ayurveda and Usual Care (AVI)
Participants receive usual care on study. Participants also receive nutrition education, lifestyle recommendations, and participate in yoga, as well as marma therapeutic touch during one-on-one AVI visits over 1-2 hours for up to 14 visits over 6 months. After 6 months, participants may also complete a videoconference visit over 30 minutes once monthly for 6 months. In addition, participants will complete online questionnaires at baseline and at the end of 6 months.
干预措施: Lifestyle Counseling (Behavioral)
Ayurveda and Usual Care (AVI)
Participants receive usual care on study. Participants also receive nutrition education, lifestyle recommendations, and participate in yoga, as well as marma therapeutic touch during one-on-one AVI visits over 1-2 hours for up to 14 visits over 6 months. After 6 months, participants may also complete a videoconference visit over 30 minutes once monthly for 6 months. In addition, participants will complete online questionnaires at baseline and at the end of 6 months.
干预措施: Yoga (Other)
Ayurveda and Usual Care (AVI)
Participants receive usual care on study. Participants also receive nutrition education, lifestyle recommendations, and participate in yoga, as well as marma therapeutic touch during one-on-one AVI visits over 1-2 hours for up to 14 visits over 6 months. After 6 months, participants may also complete a videoconference visit over 30 minutes once monthly for 6 months. In addition, participants will complete online questionnaires at baseline and at the end of 6 months.
干预措施: Quality of Life Questionnaire Administration (Other)
Health Education and Usual Care (HEI)
Participants receive usual care on study. Participants also attend online HEI sessions over 1 hour each for up to 15 sessions over 6 months. In addition, participants will complete online questionnaires at baseline and at the end of 6 months.
干预措施: Educational Intervention (Other)
Health Education and Usual Care (HEI)
Participants receive usual care on study. Participants also attend online HEI sessions over 1 hour each for up to 15 sessions over 6 months. In addition, participants will complete online questionnaires at baseline and at the end of 6 months.
干预措施: Quality of Life Questionnaire Administration (Other)
结局指标
主要结局
Proportion of all screened participants who were ultimately enrolled
时间窗: Up to 15 months
The proportion of all screened participants who were ultimately enrolled onto the study will be reported.
Proportion of eligible screens who decline to enroll
时间窗: Up to 15 months
Proportion of eligible screens who decline to enroll due to concerns about randomization will be reported.
Proportion of enrolled participants who drop out immediately after assignment
时间窗: Up to 15 months
Proportion of enrolled participants who drop out after learning their randomization assignment will be reported.
Proportion of randomized participants who drop out during participation
时间窗: Up to 6 months
Proportion of randomized participants who drop out after participating in the study interventions due to unhappiness with randomization assignment will be reported.
Retention rates
时间窗: Up to 6 months
The proportion of participants who complete \<=70% of study measures will be reported.
Adherence to intervention rate
时间窗: Up to 6 months
Proportion of participants who attended at least 10 out of 14 sessions or completed 10 out of 14 HEI sessions (≥80%) will be reported
Practitioner fidelity rates
时间窗: Up to 6 months
Fidelity of adherence to the intervention will be assessed through a contact check-list method comparing the intervention to the study manuals and the rate of adherence will be reported.
Assessment completion rates
时间窗: Up to 6 months
Assessment completion rates will be defined as the percentage of participants completing each assessment.
Mean scores on an Acceptability of Intervention measure
时间窗: Up to 6 months
The measure used for this study is a single item assessment of the implementation to participants perceived acceptability of the intervention. The response item response falls on a numeric rating scale of 0 to 10. A mean score is calculated by averaging responses from all participants. The intervention will be determined acceptable if the overall mean score is \>= 8.
Change in mean scores on an Expectation of Benefit questionnaire over time
时间窗: Up to 6 months
The change in participant's expectation of intervention benefit at baseline-pre and post randomization-will be assessed using a 0-10 numeric rating scale of 0 to 10. A mean score is calculated by averaging responses from all participants. The instrument for expectancy, is adapted from a measure created by Kalauokalani et. al, with higher scores indicating a higher level of expectation that the intervention will be beneficial.
次要结局
- Mean scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-C30)-Functional Domains over time(Up to 6 months)
- Mean scores on the PROMIS Self Efficacy over time(Up to 6 months)
- Mean scores on the EORTC-C30 Global Health Status scale over time(Up to 6 months)
- Mean scores on the EORTC-C30 Breast Cancer (BR42) subscales scale over time(Up to 6 months)
- Mean scores on the PROMIS Depressive symptoms scale over time(Up to 6 months)
- Mean scores on the PROMIS Pain scale over time(Up to 6 months)
- Mean scores on the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue scale over time(Up to 6 months)
- Mean scores on the PROMIS Sleep Disturbance scale over time(Up to 6 months)
- Mean scores on the PROMIS Anxiety scale (Short Form) over time(Up to 6 months)
- Mean scores on the Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being measure (FACIT-SP-12) over time(Up to 6 months)