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NCT Number: NCT05365230

A Randomized Trial Evaluating Personalized vs Guideline-based Well Follow-up Strategies for Patients With Early-stage Breast Cancer

After breast cancer patients complete the acute phase of their treatment (i.e. surgery, chemotherapy and/or radiation therapy), they are routinely followed in clinic every 3-6 months for several years. Multiple guideline recommendations exist with no consensus on the optimal follow-up schedule due to lack of randomized data to support any particular follow-up recommendation. Therefore the investigators propose a randomized trial evaluating personalized vs guideline-based well follow-up strategies for patients with early-stage breast cancer.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H8M2, Canada

About this study

After breast cancer patients complete the acute phase of their treatment (i.e. surgery, chemotherapy and/or radiation therapy), they are routinely followed in clinic every 3-6 months for several years. Multiple guideline recommendations exist with no consensus on the optimal follow-up schedule due to lack of randomized data to support any particular follow-up recommendation. The frequency of follow-up varies between and within different institutions. To date, no de-escalation strategy has appropriately evaluated patient reported outcomes such as quality of life or perception of care. There has been a growing body of evidence that de-intensification of follow-up is safe, effective and reduces costs for both patients and the health care system. Therefore the investigators propose a randomized trial evaluating personalized vs guideline-based well follow-up strategies for patients with early-stage breast cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being referred to the Wellness Beyond Cancer Program (WBCP) for routine follow-up after completion of acute phase of treatment for invasive breast cancer

Exclusion criteria

  • History of prior invasive breast cancer, recurrent brest cancer or metastatic breast cancer
  • Currently receiving zoledronate, LHRH (Gonadotropin-releasing hormone) or abemaciclib

Treatment and study plan

On-demand personalized follow-up care

Other

On-demand personalized follow-up care (on demand access to a WBCP nurse and an annual follow-up by telephone.

Guideline-based follow-up care (standard of care)

Other

Follow-up care based on current standard of care guidelines.

Primary outcomes

  1. Health-Related Quality of Life

    Time frame: 24 months after randomization

    Health-Related Quality of Life as determined by the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. The FACT-G is a 27-item questionnaire designed to measure four domains of Health related quality of life (HRQOL) in cancer patients: physical, social, emotional and functional well-being.

Secondary outcomes

  1. Fear of recurrence

    Time frame: 24 months after randomization

    Fear of recurrence will be measured by the Functional Assessment of Cancer Therapy - Fear of Recurrence (FACT-FRQ) questionnaire. It consists of 3 questions suggested by David Cella at FACIT (Functional Assessment of Chronic Illness Therapy), that were adapted from Vickberg's Concerns about Recurrence (CARS) questionnaire.

  2. Anxiety levels

    Time frame: 24 months after randomization

    Anxiety levels as determined by the Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS questionnaire measures anxiety and depression, which commonly coexist. It is comprised of seven questions for anxiety and seven questions for depression.

  3. Treatment related toxicity concerns

    Time frame: 24 months after randomization

    Treatment related toxicity concerns as assessed using the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire. The FACT-ES questionnaire is a validated sub scale of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. FACT-ES consists of 46 items on a 5 point Likert type scale ranging from 0 (not at all) to 4 (very much). It is designed to measure five domains of health: physical well-being, social/family well-being, emotional well-being, functional well being and endocrine symptom subscale.

  4. Recurrence-free survival

    Time frame: 24 months after randomization

    Measured by the number of participants free of breast cancer recurrence after 24 months of follow-up.

  5. Patient visits

    Time frame: 24 months after randomization

    Number of patient reported visits to different healthcare providers using a Patient Follow-up Questionnaire. The follow-up questionnaire consists of questions that assess the number of follow up visits a participant has had and also the type of healthcare provider the follow-up visits were with.

  6. Cost-effectiveness

    Time frame: 24 months after randomization

    Incremental cost-effectiveness rations (cost per one quality-adjusted life year (QALY) gained.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

A Randomized Trial Evaluating Personalized vs Guideline-based Well Follow-up Strategies for Patients With Early-stage Breast Cancer (REaCT-Wellness)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 9, 2022
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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