Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions

NCT04480203 | Recruiting

• 1 other identifier: CABC - Kreftfor project - SEB
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Breast cancer patients and age-matched controls are first invited to answer questions on HRQoL.
2. 2.Among responding breast cancer patients, a subset are invited in a randomized clinical trial with two digital interventions for cancer stress management, cognitive based stress management (CBSM) and mindfulness based intervention (MBI), as well as a control group.
3. 3.The goal is to determine whether digital CBSM or MBI can effectively reduce stress levels as compared to a control group. Second, whether these interventions can improve HRQoL (or avoid onset of HRQoL problems) for patients with breast cancer, compared to a control group.

Conditions

Breast Cancer Patients; Health, Subjective

Keywords

Health Related Quality of Life; Stress management intervention

Outcome Measures

Primary Outcomes (1)

• Stress

  Cohens perceived stress scale. Unit is summary score.

  change from CABC baseline (week 0) to f-up week 21

Secondary Outcomes (27)

• Subjective health (HRQoL)

  change from CABC baseline (week 0) to f-up week 21

• Coping

  change from CABC baseline (week 0) to f-up week 21

• Anxiety and depression

  change from CABC baseline (week 0) to f-up week 21

• Fatigue

  change from CABC baseline (week 0) to f-up week 21

• Mindfulness

  change from CABC baseline (week 0) to f-up week 21

Study Arms (3)

Cognitive based stress management (CBSM)

ACTIVE COMPARATOR

Cognitive based digital intervention.

Other: Stressproffen cognitive based stress management

Mindfulness based intervention (MBI)

ACTIVE COMPARATOR

Mindfulness based digital intervention.

Other: Stressproffen mindfulness based intervention

Control

PLACEBO COMPARATOR

Control arm. No intervention.

Other: Control

Interventions

Stressproffen cognitive based stress management OTHER

The participants will download an app (Stressproffen 2A) with cognitive based stress management.

Also known as: CBSM

Cognitive based stress management (CBSM)

Stressproffen mindfulness based intervention OTHER

The participants will download an app (Stressproffen 2B) with mindfulness based intervention.

Also known as: MBI

Mindfulness based intervention (MBI)

Control OTHER

The participants will receive no app. (They will be able to download it after the end of the 3 year study).

Control

Eligibility Criteria

• Age: 20 Years - 69 Years
• Gender Eligibility Details: Female breast cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first occurrence breast cancer diagnosed from Jan 1, 2020
• non-metastatic cancer stage 0-III
• Invasive tumors must be:
• HER2 positive (regardless of ER, PR) or
• ER negative
• (may later include other ER+ if not conflict with recruitment for EMIT/OPTIMA)

You may not qualify if:

• None

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead

Study Sites (1)

Cancer Registry of Norway

Oslo, 0379, Norway

RECRUITING

Related Publications (2)

• Svendsen K, Nes LS, Leithe S, Meland A, Gjelsvik YM, Borosund E, Larsson IM, Myklebust TA, Balto A, Rygg CM, Kiserud CE, Antoni MH, Chalder T, Mjaaland I, Carlson LE, Eriksen HR, Ursin G. Testing two digital stress-management interventions in a randomized controlled trial of breast cancer patients. Sci Rep. 2025 Nov 6;15(1):38966. doi: 10.1038/s41598-025-22889-0.

  PMID: 41198868 DERIVED

• Svendsen K, Nes LS, Meland A, Larsson IM, Gjelsvik YM, Borosund E, Rygg CM, Myklebust TA, Reinertsen KV, Kiserud CE, Skjerven H, Antoni MH, Chalder T, Mjaaland I, Carlson LE, Eriksen HR, Ursin G. Coping After Breast Cancer: Protocol for a Randomized Controlled Trial of Stress Management eHealth Interventions. JMIR Res Protoc. 2023 May 24;12:e47195. doi: 10.2196/47195.

  PMID: 37103493 DERIVED

Study Officials

• Giske Ursin, MD, PhD

  Norwegian Institute of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giske Ursin, MD, PhD

CONTACT

+4722451300; giske.ursin@kreftregisteret.no

Ine M Larsson

CONTACT

+4722928985; ine.marie.larsson@kreftregisteret.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the staff that have contact with the participants will know who receives which intervention. The statistician and investigators will be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: An intervention study of breast cancer patients with two digital intervention arms and one control group.

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 21, 2020
• Study Start: January 15, 2021
• Primary Completion: August 31, 2023
• Study Completion (Estimated): December 31, 2035
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)