AzTrials
AzTrials

Fear of Cancer RecurrenceNCT04965428

Fear-focused Self-Compassion Therapy for Young Breast Cancer Patients' Fear of Cancer Recurrence

A study testing Fear-focused Self-Compassion Therapy in people with Fear of Cancer Recurrence, run by Shaanxi Normal University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Few studies have tailored psychological intervention for fear of cancer recurrence (FCR) in young breast cancer patients, and the long-term efficacy of psychological intervention and its underlying mechanism are still unknown. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Fear of Cancer Recurrence
What is being tested?
Fear-focused Self-Compassion Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
15 Sep 2021to 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 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • (1) are diagnosed with breast cancer (including various cancer stages and subtypes);
  • (2) are aged 18-45 years;
  • (3) can sign written informed consent;
  • (4) can read and write Chinese;
  • (5) have severe FCR, with scores > 13 on the FCRI severity subscale.

Who cannot join

  • (1) currently have psychiatric and psychological illness;
  • (2) have other types of tumor;
  • (3) had a previous cancer recurrence;
  • (4) are participating another psychological intervention at the start of the study or during their eight-week therapy.

Trial locations and contacts

1 site in 1 country.

Lei Zhu, PhD contact

+8615091199645

lei.zhu@snnu.edu.cn

China1 site, 1 recruiting

  • Shaanxi Provincial Cancer Hospital

    Xi'an, Shaanxi, 710000

    Juntao Yao, 1278748172@qq.com

    Recruiting

Other trials in China

About this study

Official title: Fear-focused Self-Compassion Therapy for Young Breast Cancer Patients' Fear of Cancer Recurrence: Study Protocol of a Randomized Controlled Trial

Few studies have tailored psychological intervention for fear of cancer recurrence (FCR) in young breast cancer patients, and the long-term efficacy of psychological intervention and its underlying mechanism are still unknown. To fill this knowledge gap, this protocol aims to evaluate the short-term and long-term effectiveness of Fear-focused Self-Compassion Therapy, as well as this therapy's psychological and physiological mechanisms in reducing severe FCR in young women with breast cancer.

This study will be a randomized controlled trial recruiting 160 Chinese young female breast cancer patients with severe FCR. Participants will be randomized to the Fear-focused Self-Compassion Therapy group or control group (1:1). Measurement will be completed at baseline (T0), immediately completing intervention (T1), after 3 months (T2), after 6 months (T3) and after 12 months (T4). Primary outcomes are FCR severity; secondary outcomes are self-compassion, neurophysiological data (i.e., salivary alpha amylase and heart rate variability), attentional bias for FCR, rumination, catastrophizing thinking, and psychological symptoms. The Fear-focused Self-Compassion Therapy is based on the theories of FCR development and self-compassion, and consists of eight-week face to face group sessions.

Being tested
Fear-focused Self-Compassion Therapy
Keywords
Fear of Cancer Recurrence, Self-compassion Therapy, RCT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fear-focused Self-Compassion TherapyBehavioural

    The Fear-focused Self-Compassion Therapy will be delivered as a group format. The intervention consists of eight group face-to-face sessions (60-90 minute for each session) and will be delivered by three trained therapists for eight weeks (sessions are weekly). Each intervention group involves 10 patients.

Study groups in NCT04965428
Study groupRoleWhat they receive
Fear-focused Self-Compassion TherapyExperimentalExperimental group receives group face-to-face Fear-focused Self-Compassion Therapy for eight weeks.
Receives: Behavioral: Fear-focused Self-Compassion Therapy
Usual careNo interventionThe no intervention group receives usual care supported by hospital or coming from elsewhere for eight weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fear of cancer recurrence (FCR)

    Fear of cancer recurrence will be assessed using 42-item Fear of Cancer Recurrence Inventory (FCRI). This questionnaire consists of seven subscales, with a total score representing one's levels of FCR. A score of 13 or higher on 9-item severe subscale (ranges from 0-36) indicates a clinical FCR.

    Measured: Baseline

  2. Change from Baseline Fear of cancer recurrence (FCR) after immediately completing intervention

    Fear of cancer recurrence will be assessed using 42-item Fear of Cancer Recurrence Inventory (FCRI). This questionnaire consists of seven subscales, with a total score representing one's levels of FCR. A score of 13 or higher on 9-item severe subscale (ranges from 0-36) indicates a clinical FCR.

    Measured: After immediately completing intervention

  3. Change from Baseline Fear of cancer recurrence (FCR) at 3 months

    Fear of cancer recurrence will be assessed using 42-item Fear of Cancer Recurrence Inventory (FCRI). This questionnaire consists of seven subscales, with a total score representing one's levels of FCR. A score of 13 or higher on 9-item severe subscale (ranges from 0-36) indicates a clinical FCR.

    Measured: Baseline to 3 months

  4. Change from Baseline Fear of cancer recurrence (FCR) at 6 months

    Fear of cancer recurrence will be assessed using 42-item Fear of Cancer Recurrence Inventory (FCRI). This questionnaire consists of seven subscales, with a total score representing one's levels of FCR. A score of 13 or higher on 9-item severe subscale (ranges from 0-36) indicates a clinical FCR.

    Measured: Baseline to 6 months

  5. Change from Baseline Fear of cancer recurrence (FCR) at 12 months

    Fear of cancer recurrence will be assessed using 42-item Fear of Cancer Recurrence Inventory (FCRI). This questionnaire consists of seven subscales, with a total score representing one's levels of FCR. A score of 13 or higher on 9-item severe subscale (ranges from 0-36) indicates a clinical FCR.

    Measured: Baseline to 12 months

Secondary outcomes (7)

  1. Self-compassion

    Self-compassion will be measured by using the 12-item Self-compassion Scale-Short Form (SCS-SF) consisting of six facets: self-kindness (2 items), self-judgement (2 items), common humanity (2 items), isolation (2 items), mindfulness (2 items) and over-identification (2 items) . Responses were rated on a five-point scale from 1 (almost never) to 5 (almost always).

    Measured: Baseline, immediately completing intervention, baseline to 3 months, baseline to 6 months, baseline to 12 months.

  2. Salivary alpha amylase

    The salivary alpha amylase activity will be measured by using a hand-held salivary alpha amylase monitor manufactured by Nipro (Osaka, Japan). This analyzer can automatically measure the salivary alpha amylase activity within one minute (about 30 seconds for saliva collection and 30 seconds for analyzing). Participants will be asked to brush teeth before measurement and not allowed to intake any food, beverage, tobacco or liquor within an hour.

    Measured: Baseline and immediately completing intervention

  3. Heart rate variability (HRV)

    The HRV will be measured by using signal detection and amplification system (Biopac ECG100C) of MP150-Biopac data acquisition system. The CardioBatch will be used to compute the HRV. Participants will be asked not to intake any stimulant (e.g., caffein, alcohol), or cannot do any strenuous activity within four hours before measurement.

    Measured: Baseline and immediately completing intervention

  4. Attentional bias for FCR

    Attentional bias for FCR will be assessed by conducting the dot-probe task, including 200 trials with the stimuli of cancer-related words and utilized in previous study. The dot-probe task will be presented on a laptop computer and run by using Matlab. At the beginning of each trial, a "+" will present for 500 milliseconds in the center of the screen. After that, a pair of word stimuli with a neutral word (e.g., apple) and a cancer-related word (e.g., chemotherapy) will be presented for 500 milliseconds on the left and right sides of screen. Then, the probe stimuli will be presented at the position where the word stimuli just appear. Once the probe stimuli appear, participants should press button of the keyboard as soon as possible. After that, the screen will present 500 milliseconds of blanking, and the next trial will start.

    Measured: Baseline and immediately completing intervention

  5. Rumination

    Rumination will be measured by using the 4-item Cognitive Emotion Regulation Questionnaire Rumination Subscale (CERQ-RS). Each item of CERQ-RS ranges from 1 to 5. A higher total score means more severe rumination.

    Measured: Baseline and immediately completing intervention

  6. Catastrophizing thinking

    Catastrophizing thinking will be measured by using the 4-item Cognitive Emotion Regulation Questionnaire Catastrophizing Subscale (CERQ-CS). Each item of CERQ-CS ranges from 1 to 5. A higher total score means more severe catastrophizing thinking.

    Measured: Baseline and immediately completing intervention

  7. Psychological symptoms

    Psychological symptoms will be measured by using Hospital Anxiety and Depression Scale (HADS). This 9-item questionnaire consisting of both anxiety subscale and depression subscale, rates on five-point (0-4) scales. The total score ranges from 0 to 36, and a higher total score means more severe depression and anxiety symptoms.

    Measured: Baseline, immediately completing intervention, baseline to 3 months, baseline to 6 months, baseline to 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2021
  2. Study start15 Sep 2021
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04965428
Sponsor's protocol ID
Self-compassion FCR
Status last verified
Oct 2022
First submitted
19 Jun 2021
Last updated
26 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wei L, Yang X, Sun S, Yu Y, Xie J, Zhao J, Wang X, Zhu L, Yao J. Fear-focused Self-compassion Therapy for young breast cancer patients' fear of cancer recurrence: Study protocol of a randomized controlled trial. Front Psychiatry. 2022 Sep 23;13:941459. doi: 10.3389/fpsyt.2022.941459. eCollection 2022.

    PubMed 36213912

Questions about this trial

What is this clinical trial studying?

A study testing Fear-focused Self-Compassion Therapy in people with Fear of Cancer Recurrence, run by Shaanxi Normal University at 1 site in China.

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 5 inclusion and 4 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 26 Oct 2022. 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 China. 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 Lei Zhu, PhD (+8615091199645, lei.zhu@snnu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fear of cancer recurrence (FCR) (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04965428, which also lists 1 linked publication.

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 26 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in