Kindness Interventions in Enhancing Well-Being in Breast Cancer Survivors

NCT03319342 | Completed DMC

• 3 other identifiers: 17-000560NCI-2017-01469JCCCID776
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 2

Brief Summary

Emerging evidence suggests that both extending kindness towards others and self-kindness practices may have beneficial effects on well-being. This randomized pilot clinical trial will investigate the efficacy of two kindness interventions -acts of kindness (to self or to other) and loving-kindness meditation- for use with early-stage breast cancer survivors.

Conditions

Cancer Survivor; Stage 0 Breast Cancer AJCC v6 and v7; Stage I Breast Cancer AJCC v7; Stage IA Breast Cancer AJCC v7; Stage IB Breast Cancer AJCC v7; Stage II Breast Cancer AJCC v6 and v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage IIIA Breast Cancer AJCC v7

Outcome Measures

Primary Outcomes (2)

• Depressive symptoms (Center for Epidemiologic Studies Depression Scale)

  Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Linear mixed models provide valid inferences under a missing at random assumption. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained. Depressive symptoms will be measured at baseline and post-intervention using the 20-item Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a measure of symptom severity across the previous week, and total scores range from 0 to 60. Higher scores indicate greater severity of depressive symptoms.

  Up to 2 years

• Psychological well-being measured by the Mental Health Continuum-Short Form

  Analyses will be conducted under the intent-to-treat principle, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained. Psychological well-being measured by the Mental Health Continuum-Short Form (MHC-SF) Well-being will be measured at both baseline and post-intervention via the 14-item MHC-SF. Total scores range from 0 to 70, with higher scores indicating greater overall well-being. The MHC-SF is comprised of three empirically derived subscales: the 3-item Emotional Well-Being Subscale (score range: 0 to 15), the 6-item Psychological Well-Being Subscale (score range: 0 to 30), and the 5-item Social Well-Being Subscale (score range: 0 to 25). Higher scores on each subscale indicate greater well-being within that domain.

  Up to 2 years

Secondary Outcomes (12)

• Big-5 Personality Dimensions measured by the Ten-Item Personality Inventory (TIPI)

  Baseline

• Empathy measured by the Perspective Taking & Empathic Concern Subscales of the Interpersonal Reactivity Index

  Up to 2 years

• Fatigue measured by the Severity items of the Fatigue Symptom Inventory

  Up to 2 years

• Fulfillment of psychological needs measured by the Balanced Measure of Psychological Needs

  Up to 2 years

• Life satisfaction measured by the Satisfaction with Life Scale

  Up to 2 years

Study Arms (4)

Group I (acts of kindness to others)

EXPERIMENTAL

Participants perform small acts of kindness or generosity for others 3 times per week for 4 weeks and complete weekly online questionnaires.

Behavioral: Behavioral Intervention; Other: Questionnaire Administration

Group II (acts of kindness to self)

EXPERIMENTAL

Participants perform small acts of kindness for themselves 3 times per week for 4 weeks and complete weekly online questionnaires.

Behavioral: Behavioral Intervention; Other: Questionnaire Administration

Group III (self-kindness meditation)

EXPERIMENTAL

Participants direct kind, loving thoughts to themselves, via guided meditation, 3 times per week for 4 weeks and complete weekly online questionnaires.

Behavioral: Behavioral Intervention; Other: Questionnaire Administration

Group IV (track daily activities)

ACTIVE COMPARATOR

Participants keep track of their daily activities, focusing on factual information rather than thoughts and feelings, on 3 separate days each week. At the end of the week, participants report on their activities and complete several online questionnaires.

Behavioral: Behavioral Intervention; Other: Questionnaire Administration

Interventions

Behavioral Intervention BEHAVIORAL

Perform acts of kindness to others

Also known as: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, BEHAVIORAL THERAPY, Behavioral Treatment, Behavioral Treatments

Group I (acts of kindness to others)

Questionnaire Administration OTHER

Ancillary studies

Group I (acts of kindness to others); Group II (acts of kindness to self); Group III (self-kindness meditation); Group IV (track daily activities)

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women previously diagnosed with stage 0-IIIA breast cancer
• Have completed treatment with surgery, radiation, and/or chemotherapy
• Have not had a cancer recurrence
• Have access to the internet and an active email account

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (2)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

University of California-Riverside

Riverside, California, 92521, United States

Location

MeSH Terms

Conditions

Breast Carcinoma In Situ; Breast Neoplasms

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Julienne Bower

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 24, 2017
• Study Start: July 11, 2017
• Primary Completion: December 3, 2019
• Study Completion: December 3, 2019
• Last Updated: July 24, 2020

Record last verified: 2019-12

Locations

US (2)