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An Online Psychosocial Intervention for Fear of Cancer Recurrence in Breast Cancer Survivors

NCT05765916 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2023-03-13

No results posted yet for this study

Summary

A total of 244 breast cancer survivors will be invited to participate in the randomized controlled trial. Breast cancer survivors who meet the inclusion criteria and provide digital informed consent will be included. Participants will be stratified and randomized by the severity of baseline fear of cancer recurrence and time since diagnosis. In the control arm, women will be treated as usual. In the intervention arm, women will be offered a six-weekly, 60 min, online mindfulness and acceptance intervention. An online questionnaire will be used to collect data at four time points: before the first group session, immediately after the intervention, three months, and six months post-intervention. Phone interviews exploring participants' experiences will be held immediately after the intervention with women of the intervention group.

Conditions

Interventions

BEHAVIORAL

Online mindfulness and acceptance intervention

Session 1 aims to encourage participants to share their experiences; and introduce the purpose, content, delivery mode, duration, and frequency of the intervention. Session 2 aims to explain how negative illness perceptions lead to fear of cancer recurrence; and introduce the signs, screening, treatment and prognosis of breast cancer, ways to reduce the risk of recurrence, and symptom management. Session 3 aims to guide the participants to practice body scan and seated meditation. Session 4 aims to guide the participants to practice detached mindfulness, promoting reflection on the negative effect of indulging in unhelpful thoughts. In session 5, participants will receive several forms covering work, health, parenting style, intimate relationships, self-development and so on. Participant will be asked to choose one or two forms and set action plans. In session 6, the facilitator will invite participants to recall positive experiences and practice the "Self-care" exercise.

Sponsors & Collaborators

Principal Investigators

  • Rosalind Chiew-Jiat SIAH, Dr · National University of Singapore

  • Karis Kin Fong CHENG · Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Japan

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-07-30
Completion
2023-12-30

Countries

  • Singapore

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05765916 on ClinicalTrials.gov