Clinical trial NCT04372459: Online Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors
Official title: Online Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Psychological Distress
Emotional Disorder
Keywords: e-health
breast cancer
survivors
psychosocial care
distress
Randomised Controlled Trial
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 184
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The current clinical trial is a multicenter Randomised Controlled Trial with 2 parallel groups. The effectiveness of the online integrated and stepped psychosocial care group will be compared with the usual psychosocial care group
Primary purpose: TREATMENT

Brief summary: This multicenter randomized controlled study will appraise the effectiveness and cost-utility of an e-health ecosystem with integrated and stepped psychosocial services that will be compared with the usual psychosocial care. The study is developed in the acute survival phase among breast cancer survivors. The outcomes of both interventions will be compared in terms of the amount of waiting time to receive psychosocial care and changes in several psychosocial variables. Finally, a comparative economic analysis will be conducted in other relevant psychosocial and health parameters. The e-health platform is expected to outperform usual care in the aforementioned indicators, while reaching high acceptability and usability by survivors, and additionally reducing costs for health providers.

Detailed description: Cancer diagnosis and treatment causes a huge psychosocial impact on breast cancer survivors. Psychosocial treatments in cancer survivors have already demonstrated their effectiveness in reducing emotional distress and improving quality of life although the access to them still presents important barriers, such as poor early detection, long waiting times for diagnosis or treatment, as well as other restrictions related to work, mobility or economic situation. In addition, the current digitization of screening, monitoring and psychosocial treatment poses a revolution in the improvement of the quality of care and the reduction of its economic burden. The objectives of this study are, first, to assess the clinical efficacy of an e-health platform that includes integrated and stepped psychosocial services, in comparison to usual psychosocial care, and second, to examine its cost-utility.

The study methodology is that of a multicentre randomised controlled trial with 2 parallel groups (experimental versus control group). Approximately 193 patients diagnosed with breast cancer in the acute survival phase will be recruited from 3 University hospitals in Catalonia (Spain) and will be randomised to one of two treatment conditions. All participants will be evaluated at the beginning of the study (T1: recruitment), 3 months from T1 (T2), 6 months from T1 (T3) and 12 months from T1 (T4). Primary outcome measures will include detection of clinical cases, amount of waiting time from detection to psychosocial intervention, and proportion of cases solved in the different steps of the intervention, as well as outcomes related to emotional distress, quality of life, post-traumatic stress and growth and therapeutic alliance. Secondary outcomes will include the acceptability of the platform by patients through satisfaction questionnaires and the usability of the platform. For the cost-utility analysis, the investigators will assess quality-adjusted life years (QALYs) and costs related to the number of days of sick leaves, healthcare utilization, adherence to pharmacological treatment, health professionals' costs, infrastructure and transport costs.

The study will provide an important advance in the treatment of breast cancer; in the long term, it is expected to improve the quality of patient care and the treatment efficacy and to reduce waiting lists as well as direct and indirect costs associated with the treatment of the disease in Spain.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 70 years with BC, within 6 weeks after diagnosis.
* Having online access and a user-level knowledge of Internet.
* Understanding of Spanish language.

Exclusion Criteria:

* Major depressive episode.
* Significant autolytic ideation.
* Showing symptoms of psychosis or substance abuse.
* Intellectual disability.
* Having a mobile phone with an old release of Android operating system, which is not compatible with the platform.

Primary outcomes:
measure: Change in Emotional Distress (HADS)
timeFrame: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
measure: Change in Post-traumatic Stress (PCL-5)
timeFrame: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
measure: Change in Post-traumatic Growth (PTGI)
timeFrame: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
measure: Change in Therapeutic alliance (WAI-P)
timeFrame: Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
measure: Change in Quality of Life (EQ-5D-3L)
timeFrame: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
Secondary outcomes:
measure: Healthcare utilization
timeFrame: Time 4: 12 months post-intervention
measure: Change in Medication use and adherence (ARMS)
timeFrame: Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention
measure: Work absenteeism
timeFrame: Time 4: 12 months post-intervention
measure: Professionals' salaries
timeFrame: Time 4: 12 months post-intervention
measure: Infrastructure costs
timeFrame: Time 4: 12 months post-intervention
measure: Transport costs
timeFrame: Time 4: 12 months post-intervention
Other outcomes:
measure: Emotional wellbeing (experimental group only)
timeFrame: Administration every 7 days until the end of treatment (or study completion), an average of 1 year
measure: Health education
timeFrame: Single administration per educational topic (7 thematic blocks, 16 topics, 40 questionnaires) until the end of treatment (or study completion), an average of 1 year
measure: Usability (experimental group only) (SUS)
timeFrame: 21 days after registration
measure: Satisfaction (experimental group only)
timeFrame: 21 days after registration
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Institut Català d'Oncologia L'Hospitalet
state: Barcelona
Study officials:
affiliation: Institut Català d'Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain, 08908
name: Cristian Ochoa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ochoa-Arnedo C, Medina JC, Flix-Valle A, Anastasiadou D. E-health ecosystem with integrated and stepped psychosocial services for breast cancer survivors: study protocol of a multicentre randomised controlled trial. BMJ Open. 2021 Mar 8;11(3):e041548. doi: 10.1136/bmjopen-2020-041548.