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NCT Number: NCT05658341

Program of Physical Activity, Nutrition and Supportive to Improve the Quality of Life of Breast Cancer Survivors

Despite it being one of the leading causes of cancer death among women, survival following a breast cancer diagnosis has greatly increased in high-income countries. However; this gave rise to a growing population of women living long after breast cancer with a diminished quality of life (QoL) due to the long-term effects of cancer and cancer treatment.

Exercise can improve QoL, fatigue, and other mental and physical health outcomes in this population, and is strongly recommended among breast cancer survivors, much like a healthy diet. However adherence in real-life to these recommendations is seldom satisfactory. Also, evidence regarding the effect and cost-effectiveness of concurrent healthy lifestyle behaviors compared to exercise alone is limited. Hence the need to develop pragmatic (evaluating the effectiveness of interventions in real-life conditions) theoretical-based customized interventions, which aim to improve uptake and instill long-term adherence of health lifestyle among breast cancer survivors.

ADA (Activité physique adaptée Doublée d'un Accompagnement spécifique post-cancer) is an integrative intervention based on physical activity, nutrition and supportive care. The interventions aims to improve breast cancer survivors' physical and mental health and instill long-term healthy behaviors.

Our study will be a pragmatic two-arm (ADA intervention versus control/usual care) cluster randomized controlled trial which examines the effectiveness of the ADA intervention program.

The primary endpoint will be health-related quality of life, as measured at 12-month after the start of the trial.

Several secondary outcomes will also be assessed; which include Physical activity level, relationship to food and self-efficacy.

The study aims to recruit 160 participants in total, divided into 20 activity groups (clusters) of 8 participants.

Primary analyses will be carried out on an intention to treat (ITT) basis, at both cluster and participant level. All statistical analysis will adjust for the clustering of patients within centers as a random effect.

The aim of this trial is to provide scientific evidence on the 'real-world' effectiveness of an easily generalizable trial, with clinically-significant outcomes, touching a growing number of cancer survivors.

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Key information

Conditions

Quality of Life Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–72 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

La Rochelle, Charentes-maritimes, France

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • adult women who are between 18 and 72 years of age
  • had a diagnosis of localized breast cancer of any type, and who have completed their treatment (surgery, chemotherapy, radiotherapy) within the last 15 months, or still undergoing hormone therapy or nearing the end of their Herceptin treatment.
  • French-speaking
  • covered by the French Social Security system or benefiting from a similar health insurance system

Exclusion criteria

  • A cancer diagnosis other than breast cancer, or a relapse/metastasis of breast cancer, or generalized cancer,
  • A medical contraindication to exercise (a medical certificate of absence of contraindication to the practice of physical activity will be required, as for all physical activity in community settings).
  • Significant visual or auditory problems or behavioral problems that make it difficult to participate in group physical activity sessions.
  • a plan of moving away from the study site.
  • participating in another clinical trial
  • Male sex

Treatment and study plan

ADA

Behavioral

The 12-weeks program will include one-hour in adapted physical activity (APA), and a discussion on relaxation techniques and the undertaking of deep breathing exercises (making them APA+ sessions). A series of "minute for nutrition" short information sheets will be distributed at the end of each session.

Two workshops on "living better after breast cancer" will also be offered: one on general mobility and the other on daily nutrition.

Moreover, women will be asked to set personal challenges as a method of motivational reinforcement, and will also be called for motivational check-ins at least 3 times. Follow-up calls will allow for further individualization, motivation, and the reception of participants' concerns or remarks.

Further, participants in the intervention group will have access to a dedicated internet space containing several documents and videos on topics of concern to patients during the post-treatment phase.

Usual Care

Behavioral

Participants in the control group will be offered weekly APA sessions for 12 weeks, these sessions are based on current practices within the Siel Bleu organization. Sessions' content is adapted to people who have been treated for (all types) cancer and are based on current recommendations.

These sessions are commonly organized by Siel Bleu in hospitals, community groups or local committees of the national league against cancer organization.

Primary outcomes

  1. Health-related quality of life

    Time frame: 12 months after the beginning of the intervention

    The primary endpoint will be the health-related quality of life, as measured by the FACIT-F global score. This score is based on the 27-items Functional Assessment of Cancer Therapy-General (FACT-G) scale ,and the 13-items fatigue subscale included in the FACIT-F. Higher score indicate better Quality of life.

Secondary outcomes

  1. Physical, social, emotional, and functional well-being

    Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention

    measured separately by the FACT-G four different subscales. Higher score indicate better Quality of life.

  2. Fatigue

    Time frame: At 3 months, and 6 months after the beginning of the intervention

    measured by the FACIT-F global score. This score is based on the 13-items fatigue subscale included in the FACIT-F.

  3. Physical activity level

    Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention

    Measured with the short version of the International Physical Activity Questionnaire (IPAQ-SF).A higher IPAQ-SF score indicates a better physical activity level..

  4. Motivation for physical activity Questionnaire-2 (BREQ-2) scale

    Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention

    assessed with the short form of Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2). A higher BREQ-2 score indicates a better exercise motivation.

  5. Sedentary behavior (sitting time)

    Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention

    measured with a questionnaire adapted from the Recent Physical Activity Questionnaire (RPAQ). A higher RPAQ score indicates a lower sedentary behavior level.

  6. Relationship to food

    Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention

    Measured using a scale adapted from the Positive Eating Scale. A Higher score indicates a positive relationship with eating.

  7. Self-efficacy

    Time frame: At 3 months, 6 months, and 12 months after the beginning of the intervention

    people's beliefs about their ability to produce designated levels of performance that influence events that affect their lives, assessed by an ad-hoc scale

Study contacts

Contact information is provided by the study sponsor or research team.

Gwenn Menvielle, PhD

CONTACT

[email protected]

Nicolas Deschamps

CONTACT

[email protected]

0033607129986

Sponsors and collaborators

Lead sponsor

Siel Bleu

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Evaluating Effectiveness of an Integrative Intervention Based on Physical Activity, Nutrition and Supportive Care to Improve Quality of Life of Breast Cancer Survivors: Protocol for a Pragmatic Cluster Randomized Trial and Embedded Qualitative Study

Acronym: ADA

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 20, 2022
Registry last updated
Jul 16, 2025

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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