Evaluating an innovative support programme for older long-term cancer survivors (IMPULS-A): protocol for a randomised controlled trial.

Abstract

More than 5 million people in Germany are living with cancer or a history of cancer, 40% of them aged 75 years or older. Cancer and its treatment may lead to reduced physiological reserves, multiple somatic comorbidities and a combination of functional and psychosocial health problems in addition to the long-term and late effects of cancer and its treatment. Therefore, providing tailored care and support through an interdisciplinary care network is crucial. The aim of the IMPULS-A (Implementation of a Support Programme for Long-Term Cancer Survivors in Old Age) study is to evaluate an innovative survivorship programme designed to address the specific needs of older cancer survivors by improving access to regional care networks. IMPULS-A is a prospective, two-arm, randomised controlled trial. Altogether, n=724 cancer survivors ≥70 years, who have completed the course of first line/primary treatment, with an expected lifespan of >3 years, identified support needs and live in proximity (≤100 km) of the National Center for Tumor Diseases Heidelberg, Germany, will be randomly allocated (1:1) to an intervention or control group. All eligible participants complete study evaluation questionnaires- either via LimeSurvey or paper-based - at three time points: T0 (at randomisation), T1 (T0+9 months) and T2 (T0+18 months). The primary outcome is health literacy. Secondary outcomes are digital health literacy, quality of life, effects on preventive health measures and healthcare utilisation, personal resources, treatment satisfaction, acceptability, appropriateness and feasibility of the survivorship care model and support needs of relatives in the long-term survival phase. For participants in the intervention group, a care navigator provides appropriate referrals and information based on a biannual biopsychosocial screening. Participants with complex needs are reviewed and discussed in an interdisciplinary survivor board. Participants in the control group receive the current standard treatment. Data analysis will be performed according to the intention-to-treat principle. The primary hypothesis will be analysed using a multilevel model. Missing values will be handled using the mixed models for repeated measures method. Additionally, qualitative, semi-structured interviews with patients from both study arms will explore which aspects are important to older people in relation to a life worth living after cancer. Written informed consent will be obtained from all participants prior to study enrolment. The protocol, informed consent forms and information letters have been approved by the Ethics Committee of the Medical Faculty of Heidelberg University (S-692/2024), the Ethics Committee of the State Medical Association of Baden-Württemberg (B-F-2025-056) and the Ethics Committee of the State Medical Association of Rhineland-Palatinate (2025-18207). The study is conducted in accordance with the current version of the Declaration of Helsinki. Study results will be disseminated through publication in peer-reviewed journals and presentations at relevant scientific congresses and conferences. ISRCTN14717755.