Fear of Cancer RecurrenceNCT05765916
An Online Psychosocial Intervention for Fear of Cancer Recurrence in Breast Cancer Survivors
A study testing Online mindfulness and acceptance intervention in people with Fear of Cancer Recurrence and Breast Cancer, run by National University of Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fear of Cancer Recurrence, Breast Cancer
- What is being tested?
- Online mindfulness and acceptance intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteSingapore
- Study dates
- 30 Sep 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- with cognitive impairment such as diagnosis of Parkinson's disease
- have clinically diagnosed psychiatric disorder
- are engaging in mindfulness and acceptance intervention
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University of Singapore
Singapore
Mengmeng Lyu, +6586577205, e0529482@u.nus.edu
About this study
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.
Read the detailed description
The main study is a two-armed RCT with a 1:1 allocation ratio: (1) online psychosocial intervention; and (2) treat as usual. RCT is a gold standard for examining intervention effectiveness as it is the most reliable approach for proving the causal relationships between interventions and changes in outcome variables. Although no separate study can prove causality, randomization can reduce allocation bias stemmed from the differences in baseline variables and provides a rigorous approach for examining causality between interventions and outcome changes. Therefore, this study adopted an RCT design to examine the effectiveness of the psychosocial intervention in reducing FCR. Primary and secondary outcomes were assessed at two time points: before intervention commencement (T0) and immediate post-intervention (T1). Participants' experience in participating in the intervention was explored at the T1 through individual interview via phone call.
The magnitude of the effects of the intervention on the primary outcome of FCR and other secondary outcomes will be examined to determine if they were consistent with the existing literature. This study hypothesizes that the online psycho-social intervention will yield larger reductions in FCR and other psychosocial outcomes at post-treatment compared with a standardized care control group receiving formal follow-up care including clinical examination and health education on side-effects managements.
Research questions
Question 1: Primary outcome Is the online mindfulness and acceptance intervention effective in the reduction of FCR compared with control condition at post-intervention?
Question 2: Secondary outcomes Is the online mindfulness and acceptance intervention effective in reducing cognitive avoidance, illness representation, and in enhancing quality of life compared with the control condition?
Question 3: Participants' Experience What is the perception of the participants about the impact of the online intervention program on FCR?
- Conditions
- Fear of Cancer Recurrence, Breast Cancer
- Being tested
- Online mindfulness and acceptance intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online mindfulness and acceptance interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from the baseline FCRI score at six weeks.
Secondary outcomes (3)
Illness representation
Brief Illness Perception Questionnaire-Revised (BIPQ-R) is a nine-item self-reported instrument. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). Responses are based on a 10-point Likert scale ranging from 0 (no at all) to 10 (extremely concerned). A total score can be obtained for each subscale and for the total scale by summing the items, with higher scores indicating more negative illness perceptions. Causal representations were assessed with an open-ended response item adapted from the IPQ-R that asked patients to list the three most important causal factors in their disease (item 9). The Cronbach's alpha values of the scale was 0.77 and the split-half reliability was 0.81.
Measured: Change from the baseline score of BIPQ-R at six weeks.
Cognitive avoidance
The Impact of Event Scale (IES) is a self-administered questionnaire that designed to tap into the two most common patterns of psychological reactions associated with trauma, namely intrusiveness (individuals involuntarily has those images, thoughts, nightmares, and feelings about the traumatic events) and avoidance (individuals intentionally do not want to think or talk about the traumatic event and all matters related to it). Weiss and Marmar added six items to the IES that measured emotional arousal - certain intrusive images and thoughts that provoke anxiety and worry - to develop a 22-item IES-R. Each item was measured using 5-point Likert scales, with higher mean scores on each subscale indicate greater avoidance/intrusiveness/arousal. In this study only avoidance subscale was used. The Chinese version IES-R subscales have good internal consistency (Cronbach's α = .83-.89).
Measured: Change from the baseline score of cognitive avoidance at six weeks.
Physical, role, emotional, social and cognitive functioning
The European Organization for Research and Treatment-QOL breast cancer specific module (EORTC QOL-BR23): The 23-item EORTC QLQ-BR23 is composed of 5 dimensions to evaluate systemic therapy side effects, arm symptoms, breast symptoms, body image, and sexual functioning; 3 independent items assess sexual enjoyment, feeling of upset due to hair loss, and future perspective. These 23 items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much). Responses are based on the frequency of cancer-related symptoms or distress an individual has experienced in the past week. The initial scale has demonstrated acceptable to good internal consistency (Cronbach's alpha = 0.52 to 0.89) and moderate to strong test-retest reliability (Pearson correlations ranging from 0.54 to 0.63). The reliability of the Chinese version of the EORTC QLQ-BR53 has been examined in Chinese cancer patients (Cronbach's alpha = 0.615 to 0.923).
Measured: Change from the baseline physical, role, emotional, social and cognitive functioning at six weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start30 Sep 2022
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of Cancer RecurrenceStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LYU Mengmeng, National University of Singapore
- Investigators
- Rosalind Chiew-Jiat SIAH, Dr, Study director, National University of SingaporeKaris Kin Fong CHENG, Study director, Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765916
- Sponsor's protocol ID
- LMengmeng
- Status last verified
- Mar 2023
- First submitted
- 11 Oct 2022
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Psychosocial Intervention for Fear of Cancer Recurrence in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05765916
- Acronym / sponsor ID
- LMengmeng
- Conditions
- Fear of Cancer Recurrence, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main study is a two-armed RCT with a 1:1 allocation ratio: (1) online psychosocial intervention; and (2) treat as usual. RCT is a gold standard for examining intervention effectiveness as it is the most reliable approach for proving the causal relationships between interventions and changes in outcome variables. Although no separate study can prove causality, randomization can reduce allocation bias stemmed from the differences in baseline variables and provides a rigorous approach for examining causality between interventions and outcome changes. Therefore, this study adopted an RCT design to examine the effectiveness of the psychosocial intervention in reducing FCR. Primary and secondary outcomes were assessed at two time points: before intervention commencement (T0) and immediate post-intervention (T1). Participants' experience in participating in the intervention was explored at the T1 through individual interview via phone call.
The magnitude of the effects of the intervention on the primary outcome of FCR and other secondary outcomes will be examined to determine if they were consistent with the existing literature. This study hypothesizes that the online psycho-social intervention will yield larger reductions in FCR and other psychosocial outcomes at post-treatment compared with a standardized care control group receiving formal follow-up care including clinical examination and health education on side-effects managements.
Research questions
Question 1: Primary outcome Is the online mindfulness and acceptance intervention effective in the reduction of FCR compared with control condition at post-intervention?
Question 2: Secondary outcomes Is the online mindfulness and acceptance intervention effective in reducing cognitive avoidance, illness representation, and in enhancing quality of life compared with the control condition?
Question 3: Participants' Experience What is the perception of the participants about the impact of the online intervention program on FCR?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Online mindfulness and acceptance intervention | Experimental | Behavioral: Online mindfulness and acceptance interventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- with cognitive impairment such as diagnosis of Parkinson's disease
- have clinically diagnosed psychiatric disorder
- are engaging in mindfulness and acceptance intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online mindfulness and acceptance interventionSession 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. | Behavioural | Online mindfulness and acceptance intervention |
Primary outcome
Fear of cancer recurrence
Time frame: Change from the baseline FCRI score at six weeks.
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).
3 secondary outcomes
Illness representation
Time frame: Change from the baseline score of BIPQ-R at six weeks.
Cognitive avoidance
Time frame: Change from the baseline score of cognitive avoidance at six weeks.
Physical, role, emotional, social and cognitive functioning
Time frame: Change from the baseline physical, role, emotional, social and cognitive functioning at six weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosalind Chiew-Jiat SIAH, Dr study director
National University of Singapore
Karis Kin Fong CHENG study director
Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online mindfulness and acceptance intervention in people with Fear of Cancer Recurrence and Breast Cancer, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mengmeng Lyu (+6586577205, e0529482@u.nus.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of cancer recurrence (time frame: Change from the baseline FCRI score at six weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.