Effectiveness of a Psychosocial Intervention for Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Studies have reported about one-third to half of advanced cancer patients experience
      psychological distress yet the mental healthcare needs of these patients are not properly
      assessed and addressed. Patients with advanced colorectal cancer can face unique challenges
      that are stoma- or bowel-related in addition to other symptom burden such as pain, fatigue,
      and existential distress that have deleterious consequences on their psychological and social
      functioning. This pilot study aims to test an intervention for patients specifically with
      advanced colorectal cancer that incorporates culturally-appropriate topics. Using a
      randomized selection design, we will investigate the feasibility and acceptability of the
      intervention and obtain an initial estimate of efficacy of the intervention. This pilot study
      will yield useful information to inform the preparation of a larger, phase III confirmatory
      study.
    

Detailed description: 
      Cancer is the leading cause of death in Singapore and colorectal cancer is the most
      frequently diagnosed cancer in males and second most frequently diagnosed cancer in females,
      accounting for 17% and 13% of all cancers respectively. Such high incidence rates are
      consistent with reports of colorectal cancer being a disease of ageing and developed nations
      . A total of 8931 new cases of colorectal cancer were diagnosed in Singapore from 2009 and
      2013, with data indicating a steep increase in incidence rate for patients aged 50 and above.
      Given that the number of adults aged 65 years and older to double from 2009 to 2030
      (Singapore Department of Statistics), the number of colorectal cancer cases are also expected
      to increase.

      Advanced colorectal cancer refers to stage IV cancer of the colon or rectum that cannot be
      cured and has metastasized to at least one distant organ or set of lymph nodes, and that will
      likely continue to spread, leading to end of life (National Cancer Institute). In Singapore
      between 2009 and 2013, approximately 25% of colorectal cancer cases were at stage IV.
      According to the U.S. NCI's SEER database of patients from 2004-2010, 5-year survival rates
      for stage IV colon and rectal cancer were 11% and 12% respectively, suggesting these patients
      are or will soon be managing symptoms of their disease like pain while psychologically
      confronting end-of-life.

      The news of metastatic disease, treatment failure, and/or bleak prognosis can be demoralizing
      for some patients and characterized by shock, denial, anger, anxiety, and depression which
      can interfere with everyday living. Studies have reported about one-third to half of advanced
      cancer patients experience psychological distress and existential crises, yet studies
      indicate the needs of these patients are not properly assessed and addressed as healthcare
      providers tend to focus more on patients' physical problems and do not have the time and
      perceived competency to address emotional distress.

      Colorectal cancer comes with its own set of challenges that can significantly alter patients'
      daily living and affect patient psychological well-being and quality of life. Bowel-related
      issues have been reported to present physical, psychological, and social challenges to
      patients and survivors. For instance, patients with surgically-created stoma as part of
      treatment may face complications of leakage, skin, and odour issues that can lead to anxiety,
      disturbance in body image, low self-esteem, and social isolation. Furthermore, clinical
      anecdotes have pointed toward this patient population being concerned about lifestyle factors
      influencing their disease progression, especially diet. Psychological care has been
      increasingly recognized as an important part of treatment for this population at such a
      vulnerable time. Psychological care aims to address patients' mood and worries as they deal
      with their illness and to help patients find a sense of meaning in their life despite their
      cancer-related suffering. Unfortunately, psychological care as part of oncology supportive/
      palliative services is still very rudimentary in Singapore.

      Cognitive behavioural therapy is a widely used, evidence-based therapy that focuses on
      cognitions, emotions, and behaviour change to address patient distress. This framework has
      been successfully applied in the treatment of many disorders, including anxiety disorders,
      depression, chronic pain, and insomnia. It is posited that psycho-behavioural interventions
      (PBIs) that are based on cognitive-behavioural frameworks can be designed to meet the needs
      of cancer patients by targeting and modifying their maladaptive thoughts about the disease
      and treatment (e.g., irrational beliefs, negative attitudes, unrealistic expectations) and
      their behaviour (e.g., maladaptive coping strategies, isolation, self-negligence). This can
      be done by teaching patients strategies such as cognitive restructuring, meaning-making,
      relaxation, activity-pacing, effective communication with others, and utilization of social
      support. By learning these skills, patients are expected to have increased health-related
      self-efficacy (i.e., belief in the capacity to manage one's health) that may act as a buffer
      from them prematurely adopting the "sick role". Self-efficacy can be extremely important in
      the context of advanced cancer as it allows patients to feel more in control of a situation
      that is often distressing because of the uncertainty associated with the illness. This in
      turn may have an effect on patient psychological well-being, symptom management, and
      utilization of healthcare services such as emergency department (ED) visits and inpatient
      hospitalizations.

      The efficacy of PBIs in alleviating physical symptoms in early-stage cancer has been
      well-documented. However, the role of such intervention for advanced cancer patients is less
      clear due to lack of well-designed studies. Advanced disease has unique challenges; for
      instance, more severe physical symptoms and confrontation of existential meaning as patients
      approach end of life. This can be associated with greater distress and suffering for
      patients. A recent review noted that interpretation of the efficacy/effectiveness of PBIs for
      advanced cancer is limited by the paucity of randomized-controlled studies and lack of
      racial/ethnic diversity in patients.

      The current study aims to investigate the feasibility and acceptability of a PBI designed for
      advanced colorectal patients implemented in a Singapore context. The intervention will be
      facilitated by clinical psychologists whose specialty area is psycho-oncology, so as to allow
      in-depth discussions about suffering associated with cancer and confrontation of end-of-life
      issues. In this early phase trial, we think it is prudent to conduct the pilot intervention
      with a homogeneous cancer site so that we can teach symptom management skills that are
      specific to colorectal cancer. Additionally, we prefer to keep the disease characteristics,
      prognosis, and indicated treatments as similar as possible across our sample. Such
      homogeneity prevents the dilution of the intervention effects and facilitates the aim of
      obtaining an initial estimate of intervention efficacy. The intervention will be unique in
      that it will include a) therapeutic discussion on legacy building as a way to open discussion
      about fear of death; b) addressing changed family dynamics, which is important in an Asian
      context, and c) discussing adaptation to living with bowel-related issues that are a common
      cause of distress for this patient population. It will be important to use a
      randomized-controlled design, which is the gold-standard, to provide a definitive answer on
      the role of PBIs for advanced cancer patients.

      In summary, the significance of the study is twofold. Firstly, the proposed PBI pilot study
      will provide essential, useful information on feasibility and acceptability of providing
      low-cost, psychological care to advanced colorectal cancer patients that have the potential
      to address their distress and reduce unnecessary healthcare utilization in Singapore.
      Secondly, this would be an opportunity to add to the larger body of knowledge on the role of
      PBIs in provision of supportive care in an Asian setting and beyond. The results will be
      informative in deciding the worthiness of a phase III confirmatory study. Patients require
      support throughout the course of their cancer treatment, and currently there are gaps in
      provision of psychological care for patients with advanced cancer in Singapore's healthcare
      system. Our long-term goal is to implement evidence-based, cost-effective and scalable
      psychosocial support as a standard part of supportive care in Singapore.
    

Intervention name(s): Psycho-behavioural intervention arm (PBI)
Intervention type(s): Behavioral
Intervention description(s): The first session introduces the rationale of the intervention and is designed to encourage participants to recognize the autonomous role they can play in their health and well-being. Patients will be trained on breathing as a relaxation technique. The second session focuses on building behavioural skills to manage common symptoms for colorectal cancer patients. The third session focuses on cognitive strategies to address worries and existential distress. The last session focuses on maximizing social support and applying skills learned so far in dealing with loved ones. Participants will be provided an MP3 player that contains the relaxation exercise recording and a folder with summaries of the session content.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care