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

NCT05765916 | Unknown

• 1 other identifier: LMengmeng
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief 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

Fear of Cancer Recurrence; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Fear of cancer recurrence

  The Fear of Cancer Recurrence Inventory (FCRI) is a multidimensional self-reported instrument that assesses participants' experiences of FCR. The FCRI comprises 42 items and seven sub-scales inclusive of triggers, severity, psychological distress, functional impairment, insight, reassurance, and coping strategies. Responses are based on a 5-point Likert scale ranging from 0 (not at all or never) to 4 (a great deal or all the time). A total score can be obtained for each subscale and for the total scale by summing the items. The severity subscale is used to assess the severity of FCR. The sum of the items of severity subscale ranges from 0 to 36. Cut-offs for the severity subscale scores are as follows: nonclinical FCR, less than 13; subclinical FCR, 13 to 21; and clinically significant FCR, more than 21. The reliability and validity of the Chinese version of FCRI have been examined in 297 Chinese BCSs (Cronbach's alpha = 0.912; test-retest reliability = 0.88).

  Change from the baseline FCRI score at six weeks.

Secondary Outcomes (3)

• Illness representation

  Change from the baseline score of BIPQ-R at six weeks.

• Cognitive avoidance

  Change from the baseline score of cognitive avoidance at six weeks.

• Physical, role, emotional, social and cognitive functioning

  Change from the baseline physical, role, emotional, social and cognitive functioning at six weeks.

Study Arms (2)

Online mindfulness and acceptance intervention

EXPERIMENTAL

Participants of the intervention group will receive an intervention manual and videos. The duration of the intervention will be six weeks. Participants will be asked for a minimum time investment of 60 min per week. The intervention will be delivered via WeChat video call. The intervention will be conducted following the intervention manual to ensure consistency of intervention content that delivered.

Behavioral: Online mindfulness and acceptance intervention

Standard of care

NO INTERVENTION

Participants of the control group will be received usual follow-up care including regular medical checkups, which may include a physical exam, blood tests, and imaging tests.

Interventions

Online mindfulness and acceptance intervention BEHAVIORAL

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.

Online mindfulness and acceptance intervention

Eligibility Criteria

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

You may qualify if:

• are over 18 years old
• diagnosed with primary stage 0-III breast cancer
• have completed primary cancer treatment within ten years (ongoing endocrine therapy is permitted)
• have sub-clinical or clinical fear of cancer recurrence as defined by a score in the range of 13 to 21 or \> 21 on the fear of cancer recurrence inventory (FCRI)
• have a smart-phone
• can speak and read Mandarin

You may not qualify if:

• with cognitive impairment such as diagnosis of Parkinson's disease
• have clinically diagnosed psychiatric disorder
• are engaging in mindfulness and acceptance intervention

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

National University of Singapore

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rosalind Chiew-Jiat SIAH, Dr

  National University of Singapore

  STUDY DIRECTOR

• Karis Kin Fong CHENG

  Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Japan

  STUDY DIRECTOR

Central Study Contacts

Mengmeng Lyu

CONTACT

+6586577205; e0529482@u.nus.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a two-armed RCT with a 1:1 allocation ratio: (1) an online mindfulness and acceptance therapy-based intervention; and (2) treat as usual.

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: March 13, 2023
• Study Start: September 30, 2022
• Primary Completion: July 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)