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Background: Follow-up programs for gynecological cancer patients are currently under revision. There is limited evidence that traditional follow-up and clinical examinations improve survival in an early-stage gynecological setting. Further, traditional follow-up programs fail to accommodate the patient's need for psychosocial and sexual supportive care and to actively involve patients and their relatives in the follow-up process. Individualized programs may replace traditional routine follow-up with fixed intervals and length. Focusing on alarm-symptoms and self-reporting may ensure detection of recurrence while allowing a continuous attention to the patient's well-being and return to daily life. In this study, a nurse-led, individualized, and need-based intervention with a specific focus on patient empowerment is tested against a standard physician-led model primarily focusing on the detection of recurrence., Methods: The study is designed as a clinical, randomized trial conducted in one of four national onco-gynecological centers in Denmark. Patients with early-stage cervical or endometrial cancer are eligible for inclusion. The intervention group undergoes individualized, nurse-led follow-up supporting patient empowerment including repeated use of electronic patient-reported outcome measures (ePROMs) before each contact as a dialogue support tool. The follow-up contacts are mainly conducted by telephone. All project nurses attended a special training program before project start and are all well-educated and dedicated onco-gynecological nurses. The control group receives standard, physician-led, follow-up without use of ePROMs or specific focus on empowerment. The effect of the intervention is evaluated by questionnaires completed by patients at baseline (3 months after surgery) and 12, 18, and 36 months after surgery. Outcomes include empowerment using the Skill and technique subscale of the HEI-Q questionnaire as the primary outcome while fear of cancer recurrence and health-related quality of life as well as the remaining subscales of the HEI-Q represent secondary outcomes. Data is collected by use of the REDCap technology, which also provides a customized visual support function for the dialogue tool., Discussion: This study will provide new information about follow-up in early-stage gynecological cancer settings and thereby contribute to improvement of future follow-up programs. Importantly, the study will provide knowledge about the impact of specific focus on patient empowerment in follow-up programs and, further, how to facilitate empowerment among patients., Trial Registration: The study is registered at clinicaltrials.gov: ID no. NCT03838861. Registered on 6 February 2019. Protocol version 2, issue date 21 November 2022., (© 2023. The Author(s).)

Background: Two conceptually different morbidity outcomes unmet needs and health-related quality of life are used to identify cancer patients in need of clinical attention and to evaluate rehabilitation programmes. The knowledge on the interrelation between unmet needs and health-related quality of life is scarce. This paper studies the hypothesis that patient-perceived unmet needs of rehabilitation during the cancer trajectory are associated with decreased quality of life., Material and Methods: Based on registers, a Danish population-based cohort of adult, incident, mixed-site cancer patients diagnosed between 1 October 2007 and 30 September 2008 was established. At 14 months following diagnosis participants completed a questionnaire including health-related quality of life (EORTC QLQ C-30), psychological distress (POMS-SF), and unmet needs with regard to physical, emotional, family-oriented, sexual, work-related, and financial problems. Unmet needs were assessed through six ad hoc questions., Results: Questionnaires were received from 3439 of 4947 patients, resulting in a response rate of 70%. The three most frequent cancer types were breast (28.4%), prostate (14.6%) and colorectal cancer (15.2%). Overall, 60.1% expressed an unmet need of rehabilitation in at least one area, physical and emotional problems being the most frequent (40.0% and 37.5%). For all scales of the EORTC QLQ C-30 and POMS, significant adjusted mean differences were observed between patients with unmet needs in at least one area and patients with no unmet needs (p-values < 0.001). These differences were well above levels usually considered clinically relevant. Further, impairment increased with increasing number of areas in which unmet needs were reported., Discussion: We confirmed the hypothesis that patient-perceived unmet needs of rehabilitation during the cancer trajectory are associated with decreased quality of life. This study supports the use of unmet needs questions to identify patients in need of clinical attention. Interventions reducing cancer patients' perceived needs of rehabilitation may enhance quality of life.

Background. The effect of interventions that support rehabilitation among cancer patients has to be tested before implementation. Objective. A randomised controlled trial was conducted to test the hypothesis that a multimodal intervention may give the general practitioner (GP) an enhanced role and improve rehabilitation for cancer patients. The intervention included an interview about rehabilitation needs with a rehabilitation coordinator (RC), information from the hospital to the general practitioner about individual needs for rehabilitation and an incentive for the GP to contact the patient about rehabilitation. The objective of this first report from the study was to examine the acceptability and feasibility of the intervention. Material and methods. Adult patients treated for incident cancer at Vejle Hospital, Denmark were included between May 12, 2008 and February 28, 2009. All general practices in Denmark were randomised. Patients were allocated to intervention or control (usual procedures) based on the randomisation status of their GP. The feasibility of the intervention was analysed with regard to recruitment of patients, acceptability by patients and GPs and the degree to which the planned contacts between patients, RCs and GPs were implemented. The primary outcome of the randomised controlled trial (RCT) will be health-related quality of life at six months (EORTC-30). Results. Following assessment of 1 896 cancer patients, 955 patients (50%) registered with 323 general practices were included. The interview was conducted at the hospital with 50% of the patients in the intervention group, 31% were contacted by phone. Patients valued the fact that the conversation was dedicated to needs beyond the medical treatment. The GPs were generally available for information by phone and positive towards having a central role in the cancer rehabilitation. Discussion. It was feasible to conduct a RCT to evaluate a complex intervention in the healthcare system. All elements of the intervention were acceptable and feasible and may be implemented in future practice if the effect is positive. [ABSTRACT FROM AUTHOR]