Clinical trial NCT03319342: Kindness Interventions in Enhancing Well-Being in Breast Cancer Survivors
Official title: Kindness to Others or to Oneself: A Pilot Randomized Controlled Trial of Kindness Interventions to Enhance Well-Being in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 133
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: PRIMARY OBJECTIVES:

I. To refine two interventions - loving kindness and acts of kindness- for use with breast cancer survivors using an online platform.

II. To determine the feasibility and preliminary efficacy of these interventions on positive affect, depressive symptoms, and other aspects of well-being among women with breast cancer.

OUTLINE: Participants are randomized to 1 of 4 groups.

GROUP I (ACTS OF KINDNESS TO OTHERS): Participants perform small acts of kindness or generosity for others 3 times per week for 4 weeks and complete weekly online questionnaires.

GROUP II (ACTS OF KINDNESS TO SELF): Participants perform small acts of kindness for themselves 3 times per week for 4 weeks and complete weekly online questionnaires.

GROUP III (SELF-KINDNESS MEDITATION): Participants direct kind, loving thoughts to themselves, via guided meditation, 3 times per week for 4 weeks and complete weekly online questionnaires.

GROUP IV (CONTROL): 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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Depressive symptoms (Center for Epidemiologic Studies Depression Scale)
timeFrame: Up to 2 years
measure: Psychological well-being measured by the Mental Health Continuum-Short Form
timeFrame: Up to 2 years
Secondary outcomes:
measure: Big-5 Personality Dimensions measured by the Ten-Item Personality Inventory (TIPI)
timeFrame: Baseline
measure: Empathy measured by the Perspective Taking & Empathic Concern Subscales of the Interpersonal Reactivity Index
timeFrame: Up to 2 years
measure: Fatigue measured by the Severity items of the Fatigue Symptom Inventory
timeFrame: Up to 2 years
measure: Fulfillment of psychological needs measured by the Balanced Measure of Psychological Needs
timeFrame: Up to 2 years
measure: Life satisfaction measured by the Satisfaction with Life Scale
timeFrame: Up to 2 years
measure: Pain measured by the Pain Subscale of the Rand Health 36-item Short Form Survey
timeFrame: Up to 2 years
measure: Positive and negative affect measured by the Affect-Adjective Scale
timeFrame: Up to 2 years
measure: Qualitative assessment of acts performed
timeFrame: Up to 2 years
measure: Self-kindness measured by the Self-Compassion Scale
timeFrame: Up to 2 years
measure: Sleep disturbance measured by the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale
timeFrame: Up to 2 years
measure: Social connection measured by the Attachment Subscale of the Social Provisions Scale
timeFrame: Up to 2 years
measure: Social support measured by the 2-way Social Support Scale
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
city: Riverside
country: United States
facility: University of California-Riverside
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Julienne Bower
role: PRINCIPAL_INVESTIGATOR
References: